By 2020, it is predicted that the Biosimilar market globally will cross US$20 Billion. With an increasing number of patent expires and more clear regulation processes, Biosimilars have emerged as one of the fastest-growing categories in the bio-pharmaceutical sector. The increasing need for cost-effective treatment is one of the major factors driving this market’s growth in the coming years. Biosimilars cost 10% to 30% lesser than their parent products which is one of the primary factors fueling their adoption.
The document discusses biosimilar biological products and the FDA's guidance on them. The FDA has established an abbreviated licensure pathway for biosimilar biological products shown to be biosimilar to an FDA-licensed reference product. A biosimilar application must include analytical, animal, and clinical studies demonstrating biosimilarity based on being highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency. The FDA evaluates all the evidence submitted using a totality of evidence approach.
The document summarizes India's new guidelines for approval of biosimilar biologics. Some key points:
1) The guidelines define biosimilars as biological products claimed to be similar in safety, efficacy, and quality to an approved reference biologic.
2) Biosimilars are developed through analytical studies comparing properties to the reference product, which could reduce required clinical testing.
3) Clinical testing may include pharmacokinetic, pharmacodynamic, and safety/efficacy studies designed to establish comparability to the reference product. Post-market surveillance is also required.
4) The guidelines aim to balance regulatory standards with access to affordable biologics through a biosimilars pathway
1) The document discusses the concept of biosimilars, including their definition as biological products that are similar but not identical to an approved biologic in terms of quality, safety and efficacy.
2) It provides an overview of the regulatory approval pathways for biosimilars in the European Union, United States, and India, which generally require demonstrating biosimilarity through comparative clinical and non-clinical studies.
3) The production of biologics is more complex than small molecule drugs due to biologics' larger size, more complex structures, instability, and potential microheterogeneity.
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
Biosimilars are protein drugs that are similar but not identical to existing biologic products whose patents have expired. They offer potential cost savings compared to innovator biologics but are more complex than traditional generics. Developing biosimilars requires extensive clinical testing to demonstrate similarity due to biologics' sensitivity to manufacturing processes. Regulatory approval pathways for biosimilars are more complex than for generics and involve demonstrating similarity rather than just bioequivalence.
The document is a final report for a project selecting a polymer material for a beverage bottle. It includes sections on materials selection, statistical analysis, material properties testing, sustainability analysis, physical tests, impact testing, and economic feasibility. Three polymers were chosen for testing: polyethylene terephthalate (PET), polypropylene (PP), and polyvinylchloride (PVC). A variety of tests will be conducted on the materials to determine which polymer best meets the requirements of withstanding drops, being manufacturable at scale, and having the best combination of material properties, sustainability, and cost.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how biosimilars are regulated
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
The document discusses biosimilar biological products and the FDA's guidance on them. The FDA has established an abbreviated licensure pathway for biosimilar biological products shown to be biosimilar to an FDA-licensed reference product. A biosimilar application must include analytical, animal, and clinical studies demonstrating biosimilarity based on being highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency. The FDA evaluates all the evidence submitted using a totality of evidence approach.
The document summarizes India's new guidelines for approval of biosimilar biologics. Some key points:
1) The guidelines define biosimilars as biological products claimed to be similar in safety, efficacy, and quality to an approved reference biologic.
2) Biosimilars are developed through analytical studies comparing properties to the reference product, which could reduce required clinical testing.
3) Clinical testing may include pharmacokinetic, pharmacodynamic, and safety/efficacy studies designed to establish comparability to the reference product. Post-market surveillance is also required.
4) The guidelines aim to balance regulatory standards with access to affordable biologics through a biosimilars pathway
1) The document discusses the concept of biosimilars, including their definition as biological products that are similar but not identical to an approved biologic in terms of quality, safety and efficacy.
2) It provides an overview of the regulatory approval pathways for biosimilars in the European Union, United States, and India, which generally require demonstrating biosimilarity through comparative clinical and non-clinical studies.
3) The production of biologics is more complex than small molecule drugs due to biologics' larger size, more complex structures, instability, and potential microheterogeneity.
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
Biosimilars are protein drugs that are similar but not identical to existing biologic products whose patents have expired. They offer potential cost savings compared to innovator biologics but are more complex than traditional generics. Developing biosimilars requires extensive clinical testing to demonstrate similarity due to biologics' sensitivity to manufacturing processes. Regulatory approval pathways for biosimilars are more complex than for generics and involve demonstrating similarity rather than just bioequivalence.
The document is a final report for a project selecting a polymer material for a beverage bottle. It includes sections on materials selection, statistical analysis, material properties testing, sustainability analysis, physical tests, impact testing, and economic feasibility. Three polymers were chosen for testing: polyethylene terephthalate (PET), polypropylene (PP), and polyvinylchloride (PVC). A variety of tests will be conducted on the materials to determine which polymer best meets the requirements of withstanding drops, being manufacturable at scale, and having the best combination of material properties, sustainability, and cost.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how biosimilars are regulated
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
indian guidelines on Biosimilar Products - 07.24.12Trial_Lawyer
The document provides an overview and definitions for India's new guidelines for the approval of "similar biologics". It outlines a sequential approval process requiring comparative quality, preclinical, and clinical studies to demonstrate similarity to an authorized reference biologic. The guidelines define detailed requirements for analytical methods, quality characterization, preclinical and clinical studies, and manufacturing processes.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
This document discusses regulatory analysis and approval of biosimilars. It begins by noting key differences between biosimilars and generics, including the greater size and complexity of biologics. It then outlines guiding principles for biosimilar development and approval, including analytical studies demonstrating biosimilarity, animal studies assessing toxicity, and clinical studies of immunogenicity, pharmacokinetics, and efficacy or safety. The document discusses specific assay requirements and considerations for pharmacokinetic, structural, protein characterization, immunogenicity, and neutralizing antibody testing. It emphasizes the need to demonstrate biosimilarity through a totality of evidence from characterization, animal, and clinical studies.
This document discusses biosimilar medicines. It defines biosimilars as medicines similar to existing approved biopharmaceutical medicines. Biosimilars have similar quality, safety and efficacy profiles but are not identical. Their development and approval process is more complex than for generics due to the biological nature of biopharmaceuticals which are sensitive to manufacturing changes. Guidelines from the European Medicines Agency provide recommendations on demonstrating biosimilarity in terms of quality, non-clinical and clinical testing. Ensuring biosimilars are highly similar seeks to guarantee their safe substitution for biopharmaceuticals while increasing treatment access and lowering costs.
This presentation contains recommendations and requirements for the design of bioanalytical testing used in comparibility studies for biosimilar drug development using rituximab as an example
This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
FDA 2013 Clinical Investigator Training Course: Biosimilar Biological ProductsMedicReS
This document provides an overview of biosimilar biological products from a presentation given by Dr. Sue Lim of the FDA. It defines biological products and biosimilars. Biosimilars are developed using a stepwise approach to demonstrate biosimilarity to a reference product through analytical, nonclinical and clinical studies. Clinical study design considerations for biosimilars include using endpoints sensitive to potential differences, assessing products at time points most likely to detect differences, using the same or similar patient populations and doses as the reference product, and evaluating safety including immunogenicity over a duration adequate to detect potential impacts.
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
This document summarizes the global regulatory landscape for biosimilars. It begins by defining biosimilars and biological drugs. It then discusses the guidelines established by various regulatory bodies including the EMA, FDA, WHO, and agencies in countries like Japan, Korea, Canada, China, and India. The guidelines generally require demonstrating biosimilarity to the reference product through comparative quality, nonclinical and clinical studies. The document also discusses business opportunities for biosimilars in emerging versus established markets and strategies used by originator companies to combat biosimilar competition. It concludes by noting concerns around interchangeability between biosimilars and reference products.
This document discusses biologics and biosimilars. It defines biologics as biological products made from natural sources like humans, animals or microorganisms that are used to treat or prevent diseases. Biosimilars are highly similar versions of biologics that are approved because they have no clinically meaningful differences. The document outlines key differences between biologics and biosimilars like regulatory pathways and development testing. It also compares biosimilars to generics and discusses important considerations for biosimilar development like immunogenicity, bioequivalence and post-translational modification.
This document discusses biosimilars and their manufacturing and regulation. It defines biosimilars as biological products that are similar but not identical to already approved biologics. Their manufacturing involves analyzing the reference product and replicating its structure through living cell cultures. Biosimilars undergo clinical trials to demonstrate similarity in safety and efficacy. Regulatory approval requires demonstrating comparability to the reference product. Issues include potential differences in efficacy and immunogenicity compared to the reference product.
This document provides an overview of biologics and biosimilars. It defines biologics as complex medications made from living cells that treat diseases in novel ways. Biosimilars are highly similar but not identical copies of biologics that are approved through an abbreviated pathway. The FDA will determine standards for interchangeability and require rigorous testing to ensure biosimilars are safely effective for each condition and patient group. Important issues for patients include ensuring safety, transparency, and choice in biologic treatment.
This document provides an overview of biosimilars including their definition, categories, development principles, and regulatory approval process. Biosimilars are biological products that are highly similar to an existing approved biologic reference product. They are developed through a stepwise comparative process to demonstrate similarity in terms of safety, purity and potency. Some key points covered include:
- Biosimilars are large protein therapeutics derived from living organisms unlike traditional small molecule drugs.
- They include categories like hormones, monoclonal antibodies, and recombinant proteins.
- Their development follows principles of extensive characterization studies comparing them to the reference product.
- In India, biosimilars require approval through the regulatory pathway overseen by authorities
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biological product, known as the reference product. An interchangeable biosimilar is expected to produce the same clinical result as the reference product. Biosimilars work in the same way as the reference product through the same mechanism of action. Unlike generics, biosimilars are not necessarily identical due to differences in living organisms used to produce them. As biosimilars gain approval, they have the potential to increase treatment options for patients and lower healthcare costs.
The document discusses biosimilars and the regulatory pathway for biosimilar approval in India. It provides background on biosimilars and how they differ from generics in terms of manufacturing complexity and clinical development requirements. It summarizes India's draft biosimilar guidelines, including that phase III trials with 100+ patients are required for approval but phase I-II may be waived. The guidelines aim to streamline the process while aligning with global standards from the EMA and WHO. Over 20 biosimilars have been approved in India across several therapeutic classes.
This document discusses biosimilars and their regulation. It begins with a brief history of biotechnology and biopharmaceuticals. It then defines biosimilars as similar but not generic versions of biologic drugs whose patents have expired. The document outlines key differences between biosimilars and generic drugs, including their larger and more complex molecular structures. It also discusses concerns regarding biosimilar efficacy, safety, interchangeability, and pharmacovigilance. Finally, it provides an overview of regulatory frameworks for biosimilars in various regions like the EU, US, India, and WHO guidelines.
indian guidelines on Biosimilar Products - 07.24.12Trial_Lawyer
The document provides an overview and definitions for India's new guidelines for the approval of "similar biologics". It outlines a sequential approval process requiring comparative quality, preclinical, and clinical studies to demonstrate similarity to an authorized reference biologic. The guidelines define detailed requirements for analytical methods, quality characterization, preclinical and clinical studies, and manufacturing processes.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
This document discusses regulatory analysis and approval of biosimilars. It begins by noting key differences between biosimilars and generics, including the greater size and complexity of biologics. It then outlines guiding principles for biosimilar development and approval, including analytical studies demonstrating biosimilarity, animal studies assessing toxicity, and clinical studies of immunogenicity, pharmacokinetics, and efficacy or safety. The document discusses specific assay requirements and considerations for pharmacokinetic, structural, protein characterization, immunogenicity, and neutralizing antibody testing. It emphasizes the need to demonstrate biosimilarity through a totality of evidence from characterization, animal, and clinical studies.
This document discusses biosimilar medicines. It defines biosimilars as medicines similar to existing approved biopharmaceutical medicines. Biosimilars have similar quality, safety and efficacy profiles but are not identical. Their development and approval process is more complex than for generics due to the biological nature of biopharmaceuticals which are sensitive to manufacturing changes. Guidelines from the European Medicines Agency provide recommendations on demonstrating biosimilarity in terms of quality, non-clinical and clinical testing. Ensuring biosimilars are highly similar seeks to guarantee their safe substitution for biopharmaceuticals while increasing treatment access and lowering costs.
This presentation contains recommendations and requirements for the design of bioanalytical testing used in comparibility studies for biosimilar drug development using rituximab as an example
This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
FDA 2013 Clinical Investigator Training Course: Biosimilar Biological ProductsMedicReS
This document provides an overview of biosimilar biological products from a presentation given by Dr. Sue Lim of the FDA. It defines biological products and biosimilars. Biosimilars are developed using a stepwise approach to demonstrate biosimilarity to a reference product through analytical, nonclinical and clinical studies. Clinical study design considerations for biosimilars include using endpoints sensitive to potential differences, assessing products at time points most likely to detect differences, using the same or similar patient populations and doses as the reference product, and evaluating safety including immunogenicity over a duration adequate to detect potential impacts.
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
This document summarizes the global regulatory landscape for biosimilars. It begins by defining biosimilars and biological drugs. It then discusses the guidelines established by various regulatory bodies including the EMA, FDA, WHO, and agencies in countries like Japan, Korea, Canada, China, and India. The guidelines generally require demonstrating biosimilarity to the reference product through comparative quality, nonclinical and clinical studies. The document also discusses business opportunities for biosimilars in emerging versus established markets and strategies used by originator companies to combat biosimilar competition. It concludes by noting concerns around interchangeability between biosimilars and reference products.
This document discusses biologics and biosimilars. It defines biologics as biological products made from natural sources like humans, animals or microorganisms that are used to treat or prevent diseases. Biosimilars are highly similar versions of biologics that are approved because they have no clinically meaningful differences. The document outlines key differences between biologics and biosimilars like regulatory pathways and development testing. It also compares biosimilars to generics and discusses important considerations for biosimilar development like immunogenicity, bioequivalence and post-translational modification.
This document discusses biosimilars and their manufacturing and regulation. It defines biosimilars as biological products that are similar but not identical to already approved biologics. Their manufacturing involves analyzing the reference product and replicating its structure through living cell cultures. Biosimilars undergo clinical trials to demonstrate similarity in safety and efficacy. Regulatory approval requires demonstrating comparability to the reference product. Issues include potential differences in efficacy and immunogenicity compared to the reference product.
This document provides an overview of biologics and biosimilars. It defines biologics as complex medications made from living cells that treat diseases in novel ways. Biosimilars are highly similar but not identical copies of biologics that are approved through an abbreviated pathway. The FDA will determine standards for interchangeability and require rigorous testing to ensure biosimilars are safely effective for each condition and patient group. Important issues for patients include ensuring safety, transparency, and choice in biologic treatment.
This document provides an overview of biosimilars including their definition, categories, development principles, and regulatory approval process. Biosimilars are biological products that are highly similar to an existing approved biologic reference product. They are developed through a stepwise comparative process to demonstrate similarity in terms of safety, purity and potency. Some key points covered include:
- Biosimilars are large protein therapeutics derived from living organisms unlike traditional small molecule drugs.
- They include categories like hormones, monoclonal antibodies, and recombinant proteins.
- Their development follows principles of extensive characterization studies comparing them to the reference product.
- In India, biosimilars require approval through the regulatory pathway overseen by authorities
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biological product, known as the reference product. An interchangeable biosimilar is expected to produce the same clinical result as the reference product. Biosimilars work in the same way as the reference product through the same mechanism of action. Unlike generics, biosimilars are not necessarily identical due to differences in living organisms used to produce them. As biosimilars gain approval, they have the potential to increase treatment options for patients and lower healthcare costs.
The document discusses biosimilars and the regulatory pathway for biosimilar approval in India. It provides background on biosimilars and how they differ from generics in terms of manufacturing complexity and clinical development requirements. It summarizes India's draft biosimilar guidelines, including that phase III trials with 100+ patients are required for approval but phase I-II may be waived. The guidelines aim to streamline the process while aligning with global standards from the EMA and WHO. Over 20 biosimilars have been approved in India across several therapeutic classes.
This document discusses biosimilars and their regulation. It begins with a brief history of biotechnology and biopharmaceuticals. It then defines biosimilars as similar but not generic versions of biologic drugs whose patents have expired. The document outlines key differences between biosimilars and generic drugs, including their larger and more complex molecular structures. It also discusses concerns regarding biosimilar efficacy, safety, interchangeability, and pharmacovigilance. Finally, it provides an overview of regulatory frameworks for biosimilars in various regions like the EU, US, India, and WHO guidelines.
This document discusses biologics and biosimilars. It begins by explaining that biologics are large protein molecules derived from living cells that are used to treat diseases. Examples include human growth hormone, insulin, and monoclonal antibodies. Biosimilars are similar but not generic versions of innovator biologic products. The document outlines key differences between biologics and small molecule drugs, challenges in developing biosimilar monoclonal antibodies, and regulatory guidelines for approving biosimilars from organizations like WHO. It also discusses benefits and concerns regarding the use of biosimilars.
This document provides an overview of biosimilars. It defines biosimilars as subsequent versions of biologic medicines where patent protection has expired. Biosimilars are approved based on similarity to an original reference biologic in terms of quality, safety and efficacy, but are not expected to be identical due to structural complexities. The development of biosimilars involves extensive comparative studies to the reference product. Concerns with biosimilars include potential immunogenicity, efficacy issues, and uncertainty around switching between originator and biosimilar products or between biosimilars. Proper pharmacovigilance is important to monitor biosimilar safety and benefits.
This document provides an overview of biosimilars, which are biologic drugs that are similar but not identical to an original biologic drug (the innovator product). It discusses how biosimilars present several challenges due to the complex nature of biologics, which are produced through biotechnology rather than chemical synthesis. Specifically, it notes challenges around verifying similarity between a biosimilar and innovator, determining interchangeability, developing appropriate naming, establishing regulatory frameworks, and ensuring public safety. The document also compares key differences between biologics and traditional small molecule drugs.
This document discusses biosimilars, which are biologic products that are highly similar to approved biologic reference products. It provides background on biosimilars, including their development process, advantages, limitations, and future outlook. The development process involves producing a cell line containing the gene for the desired protein, growing cells to produce the protein, purifying the protein, and preparing it for patient use. Biosimilars offer cost savings over biologics but have concerns around immunogenicity and long-term effects when switching between products. The global biosimilar market is expected to grow significantly as biologic patents expire and more companies develop biosimilar versions of treatments.
Change your mindset – on biosimilars and genericsBiosimilars
he emerging field of Biosimilars requires some adaptation from the relevant healthcare practitioners, as these complex molecules seem to defy the known facts related to simple chemical entities. Find out why.
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of China’s biopharmaceutical industry.
In order to promote the uptake of biosimilars across the U.S., stakeholders must be informed about the basic science of these important medicines. Created out of the Biosimilars Forum's Biosimilars Roundtable (formerly the Biosimilars Forum Stakeholder Workshop group), this two page document incorporates feedback from nearly 40 stakeholder groups, from patient advocacy organizations to physician and payer groups, and presents the basic knowledge that all stakeholders need to know about the safety and efficacy of biosimilars, including answers to common myths about them.
The document summarizes the regenerative medicine industry in 2014. It provides an overview of the geographic and sector breakdown of the 418 leading regenerative medicine companies tracked by the Alliance for Regenerative Medicine. The majority are therapeutics and devices companies developing cell therapies, gene therapies, and cell-based immunotherapies. Primary cell therapies and stem cell therapies represent the most mature areas. The report also highlights significant anticipated clinical milestones and results in 2014 and the increasing investment in regenerative medicine by large pharmaceutical companies.
This document summarizes an upcoming conference on biosimilars and biobetters to be held in London from September 29-30, 2014. The conference will include presentations and discussions on accelerating biosimilar drug development, regulatory pathways for biosimilars in Europe and the US, proving biosimilarity to reference products, and perceptions of biosimilars among doctors, patients, and payers in Europe. Attendees can also participate in two interactive workshops on biosimilar regulations and the commercial potential of biosimilars. Various industry experts will speak at the event to provide insights on this emerging field.
Biosimilars, a pharmacist’s perspectiveBiosimilars
This document discusses how biosimilars may profoundly impact the role of pharmacists. Biosimilars are similar but not identical to biologic drugs, and slight manufacturing differences can impact a biosimilar's effects. This requires pharmacists to refrain from automatically substituting biosimilars and become more familiar with their potential side effects and immunogenic responses. The document also notes that future posts will explore challenges for hospital pharmacists providing biosimilars and provide additional educational resources on biosimilars.
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Biosimilar & Patents - Challenges for Research & Analysis
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Title: Biosimilar & Patents - Challenges for Research & Analysis
IKS Category: Biopharmaceutical and Patenting
IKS Article No: IKS_Biopharma_01 Rev_1_July_20_2017
Compilation by: Mayuri Butani; Pritesh Gohel; Chintan Modi; Tejas Patel
Why This Series?
Technology is shaping the world around us. Every day we come across
the new ideas and new technology. We believe in “WE SHARE, WE
GROW”. We believe in sharing what we learn and learning further by
receiving your feedback on IKS@intellectperitus.com
Why This Article?
We learned that Biosimilar is an area in which searching prior art is a
challenge. We accepted this challenge and we learned what the related
areas are which pose challenges and what can be the remedies around
those challenges.
Our Disclaimer:
We undergo rigorous study of various materials available in books,
journals, conference proceedings, trade magazines, catalogs/manuals,
blogs and general web search. We have provided references as much as
possible. Feel free to contact us if you believe that we have used any
copyrighted material without providing references. We apologize.
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CONTENTS:
1. Abstract ............................................................................................................................ 3
2. Introduction to Biosimilar: ............................................................................................... 4
2.1. Biological Products, Biosimilar and Interchangeable ............................................... 4
2.2. Why biosimilars are not considered as generic medicines?.................................... 5
3. Biosimilar in USA:............................................................................................................ 6
3.1. Biologics Price Competition and Innovation Act 2009.............................................. 6
3.2. Biosimilar Interchangeability:...................................................................................... 7
3.3. The “Purple Book”: ...................................................................................................... 8
3.4. Biosimilars Approved in USA:..................................................................................... 8
4. Biosimilar in Europe: ....................................................................................................... 9
4.1. Legislation Directive 2001/83/EC............................................................................... 9
4.2. Biosimilar Interchangeability:.................................................................................... 10
4.3. Biosimilars Approved in Europe: .............................................................................. 11
5. Biosimilar in India: ......................................................................................................... 12
5.1. CSIR Guidelines: ....................................................................................................... 12
5.2. Biosimilars Approved in India: .................................................................................. 12
6. Patent Research & Analytics Challenges for Biosimilars:.......................................... 13
References: ........................................................................................................................... 14
About IntellectPeritus............................................................................................................ 15
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Biosimilar & Patents - Challenges for Research & Analysis
1. Abstract
By 2020, it is predicted that the Biosimilar market globally will cross US$20 Billion. With
an increasing number of patent expires and more clear regulation processes, Biosimilars
have emerged as one of the fastest-growing categories in the biopharmaceutical sector.
The increasing need for cost-effective treatment is one of the major factors driving this
market‟s growth in the coming years. Biosimilars cost 10% to 30% lesser than their
parent products which is one of the primary factors fueling their adoption. This article
mainly focuses on what is Biosimilar, overview of regulation, products approved related
to Biosimilar in USA, Europe & India and few challenges in patent researching and
analysis related to Biosimilars.
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2. Introduction to Biosimilar:
2.1. Biological Products, Biosimilar and Interchangeable
2.1.1. Biological Products:
Biological products are made from living organisms. The material they are made from
can come from many sources, including humans, animals and microorganisms such as
bacteria or yeast. Biological products are manufactured through biotechnology, derived
from natural sources or, in some cases, produced synthetically.
Many of today‟s important medications are biological products. Biological products are
among the medications used to treat conditions such as rheumatoid arthritis, anemia,
Alzheimer‟s disease, multiple sclerosis, low white blood cell counts, inflammatory bowel
disease, skin conditions such as psoriasis, various forms of cancer and other serious
diseases.
Types of Biological products are: blood and blood products, proteins, vaccines,
allergenic extracts, human cells and tissues used for transplantation, gene and cellular
therapies. [1] Table 1 lists the example of biological products with technology
classification.
Name
Trade
Name
Technology Indication
Erythropoietin Epogen Recombinant protein
Anemia arising from cancer
chemotherapy, chronic renal
failure,
Etanercept Enbrel
Recombinant human
TNF-receptor fusion
protein
Rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis,
psoriasis
Adalimumab Humira Monoclonal antibody
Rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis,
psoriasis, ulcerative colitis,
Crohn's disease
Table 1: Example of Biological Products
2.1.2. Biosimilar:
Biosimilars are a type of biological products that are approved by regulatory authorities
because they are highly similar to an already approved biological product, known as the
biological reference product and have been shown to have no clinically meaningful
differences from the reference product. Minor differences in clinically inactive
components are allowed, but there must be no clinically meaningful differences between
the biosimilar and the reference product when it compared in terms of the safety, purity
and potency of the product. [2, 3]
2.1.3. Interchangeable:
An Interchangeable biological product is biosimilar to the reference product that meets
additional standards for interchangeability and is expected to produce the same clinical
result as of the reference product in any given patient, and for a product that is given to a
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patient more than once, the risk in terms of safety and effectiveness of alternating or
switching between the interchangeable and the reference product is not greater than the
risk of using the reference product without alternating or switching. [2]
2.2.Why biosimilars are not considered as generic medicines?
A biosimilar is not regarded as a generic of a biological medicine. This is mostly because
the natural variability and more complex manufacturing of biological medicines do not
allow an exact replication of the molecular microheterogeneity. The generic drugs are
copies of brand-name drugs, have the same active ingredient, and are the same as
those brand name drugs in dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use. That means the brand-name and the
generic are bioequivalent. Biosimilars are highly similar to the reference product they
were compared to, but have allowable differences because they are made from living
organisms. Biosimilars also have no clinically meaningful differences in terms of safety,
purity, and potency from the reference product. [1, 4, 6]Table 2 lists the differences
between the generic medicine vs. Biosimilar medicine.
Table 2: Comparison between Generics and biosimilars [1, 4, 5, 6]
Generic Medicine Biosimilar Medicine
Size Smaller molecules
Larger, structurally more complex
molecules
Characterization Easier to characterize
Require multiple technologies for their
characterization
Source
Usually produced by chemical
synthesis
Obtained from a biological source
Production Generally possible to obtain
exactly the same molecule
Possible to reproduce the molecule to a
high degree of similarity due to unique
bio-manufacturing methods and natural
biological variability
Pre-approval
Clinical data requirements are
mainly pharmacokinetic
bioequivalence studies
In addition to comparative
pharmacokinetic and pharmaco-
dynamic studies, safety and efficacy
data may be required, particularly for
more complex biological medicines
Structure
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3. Biosimilar in USA:
3.1.Biologics Price Competition and Innovation Act 2009
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) which is
amendment to Public Health Service Act (PHS Act) creates an abbreviated licensure
pathway for biological products that are demonstrated to be “biosimilar” to or
“interchangeable” with an FDA-licensed biological product (42 U.S.C. §262(k)). [2]
As per 42 U.S.C. §262(k)(2) the manufacturers must submit a 351(k) biologics license
application (BLA) that includes, among other things, information demonstrating
biosimilarity based upon:
• Analytical studies demonstrating that the biological product is “highly similar” to
the reference product notwithstanding minor differences in clinically inactive
components
• Animal studies (including the assessment of toxicity)
• A clinical study or studies (including the assessment of immunogenicity and
pharmacokinetics (PK) or pharmacodynamics (PD)) sufficient to demonstrate
safety, purity, and potency in 1 or more appropriate conditions of use for which
the reference product is licensed and for which licensure is sought for the
biosimilar product. [2]
The BPCI Act (42 U.S.C. §262(k)(7)) provides reference biological drug products 12
years of marketing exclusivity for new “biological structures”. If a biosimilar application is
filed by the same manufacturer of the pioneer product (or a related party), the changed
biological structure must also result in
• Change in indications, route of administration, dosing schedule, dosing form,
delivery system, delivery device or strength
• Change in safety, purity or potency, new 12-year exclusivity period is to be
awarded [2]
An application for Interchangeable can file after four years of biologic structure (12-year)
exclusivity. [2]
Once the first interchangeable product has been approved, no subsequent
interchangeable applications will be approved until one year after the first commercial
marketing of interchangeable biosimilar biological product. This Timeline is extendable in
case of litigation (42 U.S.C. §262(k)(6)). [2]
The pediatric exclusivity under the BPCI Act adds six months to 12-year exclusivity and
six months to the four-year filing restriction (42 U.S.C. §262(m)(3)). [2]
As per 42 U.S.C. §262(i)(1) the Biosimilar applicant learns of the patents that protect the
pioneer biologic only after providing the pioneer with confidential access to its application
and related manufacturing process. The biosimilar applicant and pioneer then undertake
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a complex exchange of patent information (the “patent dance”) over an approximate
two-month period to compile a list of “agreed to” patents that will be subject to a “first
wave” of pre-launch litigation. The pioneer then has 30 days to file suit on those patents
to enjoin biosimilar launch or else only royalties can be obtained in subsequent litigation
on those patents.
The U.S. Supreme Court on June 12, 2017 interpreted the BPCI act such that the
biosimilar patent dance is not mandatory in SANDOZ INC. v. AMGEN INC. ET AL. The
Supreme Court decided that Applicant of Biosimilar did not violate the BPCI Act by failing
to engage in the patent dance, as consequences for failure to do so are expressly stated
in the BPCI Act – meaning that failure to participate was expressly contemplated by the
BPCI Act. The Court explained that failing to disclose its application and manufacturing
information as required under 42 U.S.C. §262 (l)(2)(A) does not constitute an act of
artificial infringement, but is actionable under 42 U.S.C. §262 (l)(9)(C), which permits the
sponsor to bring an immediate declaratory judgment action for artificial infringement. [7]
The BPCI Act also provides for a “second wave” of pre-launch litigation by requiring the
biosimilar applicant to notify the pioneer a second time at least 180 days prior to launch.
Patents that were disclosed, but not on the “agreed to” list during the first dance, are
eligible for possible injunctive relief, and applicants can file Declaratory Judgments
during this second wave on patents that the pioneer elects not to pursue (42 U.S.C. §262
(i)(8)). [2, 7]
3.2.Biosimilar Interchangeability:
The USFDA on January 17, 2017 released a draft guidance detailing the agency's
expectations for demonstrating biosimilar interchangeability.
FDA proposed Biosimilar applicant should consider an array of factors ("totality of
factors") when determining the type and amount of data to support a demonstration of
interchangeability, including product complexity and product-specific immunogenicity
risk.
According to FDA, switching studies should be designed to determine whether
alternating between a biosimilar and its reference product two or more times impacts the
safety or efficacy of the treatment course. However, if the product is only intended to be
administered once, Biosimilar applicant may instead provide a justification for not
needing to conduct a switching study.
FDA also says that Biosimilar applicant should carefully consider their product
presentation, including the delivery device and container closure system, as differences
in presentation may affect FDA's determination of interchangeability. Applicant should
not try to get an interchangeable biosimilar approved with a different type of presentation
than the reference product. [8]
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3.3.The “Purple Book”:
The “Purple Book” lists biological products, including any biosimilar and interchangeable
biological products, licensed by FDA under the Public Health Service Act (the PHS Act).
The Purple Book includes the date a biological product was licensed and whether FDA
evaluated the biological product for reference product exclusivity. The Purple Book, in
addition to the date licensed, also includes whether a biological product has been
determined by FDA to be biosimilar to or interchangeable with a reference biological
product (an already-licensed FDA biological product) [9]
3.4.Biosimilars Approved in USA:
Table 3 lists biological products approved in USA.
Biosimilar Product Reference Product Date of Approval
Filgrastim-sndz / Zarxio / Sandoz Filgrastim / Neupogen / Amgen March 6, 2015
Infliximab-dyyb / Inflectra / Celltrion Infliximab / Remicade / Janssen April 5, 2016
Etanercept-szzs / Erelzi / Sandoz Etanercept / Enbrel / Amgen August 30, 2016
Adalimumab-atto / Amjevita / Amgen Adalimumab / Humira / AbbVie September 23, 2016
Infliximab-abda / Renflexis / Samsung
Bioepsis
Infliximab / Remicade / Janssen April 21, 2017
Table 3: Biosimilars approved in USA [10]
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4. Biosimilar in Europe:
4.1.Legislation Directive 2001/83/EC
The EU has pioneered the regulation of biosimilars since the approval of the first one
(the growth hormone somatropin) in 2006 with legislation Directive 2001/83/EC, as
amended (2004/27/EC) in March 2004: Article 10.4. [11]Since biosimilars are a type of
biological medicine, all features pertinent to biological medicines apply.
The biosimilar has physical, chemical and biological properties highly similar to that of
the reference medicines. There may be minor differences from the reference medicine
which are not clinically meaningful in terms of safety or efficacy. Minor variability is only
allowed when scientific evidence shows that it does not affect the safety and efficacy of
the biosimilar. The range of variability allowed for a biosimilar is the same as that allowed
between batches of the reference medicine. This is achieved with a robust
manufacturing process to ensure that all batches of the medicine are of proven quality.
[4]
The exclusivity period provision in Europe is the same for both biologics and chemical
drugs. All medicines produced using biotechnology and those for specific indications
(e.g. for cancer, neurodegeneration and auto-immune diseases) must be approved in the
EU through EMA (European Medicines Agency) also known as „centralized procedure‟.
Nearly all biosimilars approved for use in the EU have been approved centrally, as they
use biotechnology for their production. Some biosimilars may be approved at national
level, such as some low-molecular weight heparins derived from porcine intestinal
mucosa. [4]
When a company applies for marketing authorization at EMA, data are evaluated by
EMA‟s scientific committees on human medicines and on safety (the CHMP and PRAC),
as well as by EU experts on biological medicines (Biologics Working Party) and
specialists in biosimilars (Biosimilar Working Party). The review by EMA results in a
scientific opinion, which is then sent to the European Commission, which ultimately
grants an EU-wide marketing authorization. Image 1 depicts steps of Biosimilar
development. [4]
Image 1: Biosimilar Development in steps [4]
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4.2.Biosimilar Interchangeability:
The terminology to refer to interchangeability and substitution practices in the EU:
Interchangeability refers to the possibility of exchanging one medicine for another
medicine that is expected to have the same clinical effect. This could mean replacing a
reference product with a biosimilar (or vice versa) or replacing one biosimilar with
another. Replacement can be done by:
• Switching (Physician Decision) - the prescriber decides to exchange one
medicine for another medicine with the same therapeutic intent.
• Substitution (automatic) (Pharmacist action) - practice of dispensing one
medicine instead of another equivalent and interchangeable medicine at
pharmacy level without consulting the prescriber.
As per provision EMA carries out the scientific review of a biosimilar, the evaluations do
not include recommendations on whether the biosimilar is interchangeable with the
reference medicine, and thus whether the reference medicine can be switched or
substituted with the biosimilar. The decision on whether to allow interchangeable use
and substitution of the reference biological medicine and the biosimilar is taken at
national level. [4]
There is convergence across EU countries that biologic medicines should not be
substituted at the pharmacy level without the involvement of the clinical decision maker.
[13] Image 2 provides switching policy in Biosimilars.
Image 2: Biosimilars switching policy [4]
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4.3.Biosimilars Approved in Europe:
More than 25 biosimilars are approved in EU. Few of them are listed in Table 4 below:
Product
Active
Substance
Manufacturer /
Company
Authorization
Date
Reference
Drug
Binocrit
epotein alfa
Sandoz 28-Aug-07
Eprex / Erypo
Epoetin Alfa
Hexal
Hexal 28-Aug-07
Silapo
epotein zeta
Stada 18-Dec-07
Retacrit Hospira 18-Dec-07
Accofil
filgrastim
Accord 18-Sep-14
Neupogen
Filgrastim Hexal filgrastim 6-Feb-09
Nivestim Hospira 8-Jun-10
Zarzio Sandoz 6-Feb-09
Inhixa
enoxaparin
sodium
Techdow Europe 15-Sep-16
Clexane
Thorinane Pharmathen 15-Sep-16
Flixabi
Infliximab
Samsung Bioepis 26-May-16
RemicadeInflectra Hospira 10-Sep-13
Remsima Celltrion 10-Sep-13
Benepali etanercept Samsung Bioepis 14-Jan-16 Enbrel
Table 4: Biosimilars approved in Europe [14]
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5. Biosimilar in India:
5.1.CSIR Guidelines:
The Central Drugs Standard Control Organization is the national regulatory body of India
released new guideline for biosimilars which is effective from August 15, 2016. The new
guideline is a slight change of the previous Biosimilars guideline “Draft Guidelines on
Similar Biologics: Regulatory Requirements for Marketing Authorization in India”
released in 2012. The 2012 Guideline on similar biologics address the pre-marketing and
post-marketing regulatory requirement (i.e. “comparability exercise”), and also address
the requirements related to manufacturing process and quality control. [15]
India has adopted a “sequential approach” (like “stepwise approach” - US and EU) to
market biosimilar products. The 2016 guidelines focus more on Post marketing. The
major change mentioned in new guideline is the Reference product. If the reference
product is not marketed in India, it can be licensed in any ICH country. [16]
5.2.Biosimilars Approved in India:
More than 25 biosimilars are approved in India. Few of them are listed in Table 5 below
Product
Active
Substance
Company Approval / Launch Date
Epofer
epoetin alfa
Emcure Not Reported
Epotin Claris Lifesciences Not Reported
Erypro Biocon Not Reported
Erykine
Intas
Biopharmaceuticals
August 2005
Wepox Wockhardt March 2001
Fegrast
Filgrastim
Claris Life Sciences Not Reported
Grafeel Dr. Reddy‟s Laboratories Not Reported
Neukine
Intas
Biopharmaceuticals
July 2004
Nufil Biocon Not Reported
Choriorel
Chorionic
gonadotrophin
Reliance Life Sciences Not Reported
Cresp Darbopoetin alfa Dr. Reddy‟s Laboratories August 2010
Table 5: Biosimilars approved in India [17]
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6. Patent Research & Analytics Challenges for Biosimilars:
Patent research and analytics of Biosimilars is challenging and time-consuming because
of
• Complex structure and function of Biological molecules
• Various keywords for same biological molecule like brand name, generic name,
keywords based on target site, keywords based on mode of action, acronyms,
abbreviations, spelling variations and truncations, etc.
For example: For Adalimumab, Keywords can be Adalimumab, Humira, Trudexa,
Amjevita, humanized monoclonal antibody, human monoclonal antibody, anti-
TNF mAb, anti-TNF monoclonal antibodie, D2E7 Heavy chain, D2E7 Light chain,
TNF-α, TNF-alpha, hTNFα, hTNF, TNFA, TNFSF2, etc.
• Like Chemical Structure search in chemical molecules, Sequence search (Nucleotide
and Protein) in Biosimilars is key and universal approach. Not only 100% match
sequence is relevant as chances are there that part of entire sequence is claimed.
Difficulties of determining fragment of sequence considered as relevant.
• Multiple assignees work on same Biosimilar and file patent applications. You need to
be very careful in collecting patent documents of all assignees considering in mind
complete corporate hierarchy of companies.
• Companies developing Biosimilars tend to file patent applications vigorously. One
patent family could be large to contain hundreds of patents and applications. The
family is having patent documents related to Biosimilar as well as all its possible
variations. Hence challenge is to isolate patent documents which are relevant for
Biosimilar of our interest.
For Example, a patent family of US6090382 covering Humira (Adalimumab)
assigned to BASF contains 129 publications (INPADOC family members)
• Apart from product patent covering Biosimilar, we must take care of patents claiming
composition, Process of manufacturing / screening / purification / characterization,
method of use, etc. You must need to see expiry of all these.
For example, For Adalimumab (Humira), product patent covering Adalimumab
expired in end of 2016, but still more than 70 patents are alive wherein 14 patents
are on Humira Formulation, more than 20 patents on method of manufacturing
and more than 20 patents on method of treatment.
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References:
1. U.S. Food and Drug Administration. Consumer Updates: Regulating Biological Products; 2008.
Available from: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm
2. Office of the Law Revision Counsel; 42 USC § 262: Regulation of biological products.
3. European Medicines Agency. Overview: Biosimilar Medicines. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&
mid=WC0b01ac0580bb8fda
4. European Medicines Agency. Information guide for healthcare professionals: Biosimilars in the EU;
2017. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
5. Sekhon SB, Saluja V; Biosimilars: An overview; Biosimilars, Volume: 2011, Issue:1, Pages:1-11; 2011.
6. Müller R, Renner C, Gabay C, Cassata G, Lohri A, Hasler P; The advent of biosimilars: Challenges and
risks; Swiss Medical Weekly, Volume: 144:w13980; 2014.
7. Supreme Court of the United States. Sandoz INC. v. AmgeN INC. et al.; Syllabus, No.: 15-1039; June
12, 2017.
8. US Food and Drug Administration. Draft Guidance, Guidance for Industry: Considerations in
Demonstrating Interchangeability with a Reference Product; January 2017. Available from:
Product.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM537135.pdf
9. US Food and Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Available from:
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvala
pplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm
10. US Food and Drug Administration. Center for Drug Evaluation and Research: List of Licensed Biological
Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to
Date. Available
from:https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand
Approved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf
11. Official Journal of the European Union. The European Parliament, Directive 2004/27/EC; March 31,
2004. Available from: http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-
1/dir_2004_27/dir_2004_27_en.pdf
12. European Medicines Agency. Data exclusivity / Generics / Biosimilars: Regulatory and procedural
guidance; 2008. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000
211.jsp&mid=WC0b01ac0580031b0a
13. Medicines for Europe. Biosimilar Medicines, Memo: Positioning Statements on Physician-led Switching
for Biosimilar Medicines; April 2017. Available from: http://www.medicinesforeurope.com/wp-
content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf
14. European Medicines Agency. European public assessment reports: Biosimilars. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&m
id=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&st
atus=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searc
hGenericType=biosimilars
15. Government of India, Department of Biotechnology, Central Drugs Standard Control Organization.
Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2012.
Available from: http://www.cdsco.nic.in/writereaddata/Bio%20Similar%20Guideline.pdf
16. Government of India, Department of Biotechnology, Central Drugs Standard Control Organization.
Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2016.
Available from: http://www.ableindia.in/images/resources/1471597420-
Guidelines%20on%20Similar%20Biologics%20wef%2015%20Aug%202016.pdf
17. GaBI Online - Generics and Biosimilars Initiative. „Similar biologics‟ approved and marketed in India;
September 9, 2012. Available from: http://www.gabionline.net/Biosimilars/General/Similar-biologics-
approved-and-marketed-in-India
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