Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #1 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
The document compares the regulatory processes for drug product submissions in the US and EU. In the US, applications are submitted to the FDA's Center for Drug Evaluation and Research and can be New Drug Applications or Abbreviated New Drug Applications. In the EU, applications are submitted through national regulatory authorities or through the centralized European Medicines Agency process. The key differences between the US and EU processes include differences in application types, approval timelines, post-approval change requirements, manufacturing standards, quality testing standards, and facility inspection processes.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
The document compares the regulatory processes for drug product submissions in the US and EU. In the US, applications are submitted to the FDA's Center for Drug Evaluation and Research and can be New Drug Applications or Abbreviated New Drug Applications. In the EU, applications are submitted through national regulatory authorities or through the centralized European Medicines Agency process. The key differences between the US and EU processes include differences in application types, approval timelines, post-approval change requirements, manufacturing standards, quality testing standards, and facility inspection processes.
This document provides definitions and guidelines regarding bioequivalence and bioavailability testing requirements for generic drug approvals. It defines key terms like bioavailability, bioequivalence, and pharmaceutical equivalents. It outlines the types of evidence and study designs required to demonstrate bioequivalence to the reference listed drug, including in vivo blood level studies, in vitro dissolution testing, and possible clinical endpoint studies. It also discusses statistical analysis methods and factors that can impact bioequivalence studies.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
Abbreviated New Drug Application (ANDA)RaghaviPillai
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
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.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
This document provides an overview of paper NDAs (new drug applications), which allowed generic drug companies to rely on published literature to demonstrate the safety and efficacy of reference drugs whose patents had expired. It discusses the history and implementation of paper NDAs, how they worked, and how they were replaced by the 505(b)(2) application pathway established by the Hatch-Waxman Act of 1984 to streamline the approval of generic drugs.
This document provides a checklist of documents required for obtaining market authorization in various BRICS countries. It introduces BRICS as an emerging market comprising Brazil, Russia, India, China and South Africa. Reasons for the emergence of BRICS markets include declining growth in developed markets and availability of patient populations in emerging markets. The checklist then outlines the documents required for market authorization from the regulatory authorities in India, China, South Africa and other BRICS countries. These include application forms, composition details, clinical trial reports, GMP certificates, and other product-specific documents.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
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 provides definitions and guidelines regarding bioequivalence and bioavailability testing requirements for generic drug approvals. It defines key terms like bioavailability, bioequivalence, and pharmaceutical equivalents. It outlines the types of evidence and study designs required to demonstrate bioequivalence to the reference listed drug, including in vivo blood level studies, in vitro dissolution testing, and possible clinical endpoint studies. It also discusses statistical analysis methods and factors that can impact bioequivalence studies.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
Abbreviated New Drug Application (ANDA)RaghaviPillai
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
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.
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
This document provides an overview of paper NDAs (new drug applications), which allowed generic drug companies to rely on published literature to demonstrate the safety and efficacy of reference drugs whose patents had expired. It discusses the history and implementation of paper NDAs, how they worked, and how they were replaced by the 505(b)(2) application pathway established by the Hatch-Waxman Act of 1984 to streamline the approval of generic drugs.
This document provides a checklist of documents required for obtaining market authorization in various BRICS countries. It introduces BRICS as an emerging market comprising Brazil, Russia, India, China and South Africa. Reasons for the emergence of BRICS markets include declining growth in developed markets and availability of patient populations in emerging markets. The checklist then outlines the documents required for market authorization from the regulatory authorities in India, China, South Africa and other BRICS countries. These include application forms, composition details, clinical trial reports, GMP certificates, and other product-specific documents.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
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.
Diem Nguyen, regional president of North America for Global Established Pharmaceuticals at Goldman Sachs, presented at a biosimilars conference on April 2, 2015. The presentation discussed the attractive growth opportunity for biosimilars, with the market expected to reach $20 billion by 2020. It noted biosimilars have the potential to expand access to important medicines while providing savings to healthcare systems. However, biosimilars are complex to produce and require significant expertise in manufacturing. Pfizer believes policies should be based on science and physicians should have the ability to choose the treatment that is best for their patients. Pfizer is well positioned in the biosimilars space due to its capabilities and experience developing
The document summarizes a presentation given by Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines (ASBM), about biosimilars and challenges in bringing them to patients. Some key points:
- Biosimilars provide increased treatment options and potential cost savings compared to reference biologics, but developing and approving biosimilars faces more challenges than generic drugs due to biologics' larger and more complex molecular structure.
- Physician confidence and acceptance is important for biosimilar use, but indication extrapolation and lack of long-term clinical data are concerns that could limit adoption.
- Through surveys of physicians worldwide, ASBM is providing data on physician perspectives to regulators
Hope S. Rugo, MD, FASCO, prepared useful Practice Aids pertaining to biosimilars for this CME/MOC/CNE/CPE activity titled "Biosimilars as Partners in Oncology: Expert Guidance on Understanding and Incorporating Biosimilar Agents in Real-World Care." For the full presentation, monograph, complete CME/MOC/CNE/CPE information, and to apply for credit, please visit us at http://bit.ly/38DBgFb. CME/MOC/CNE/CPE credit will be available until April 27, 2021.
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 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
Biologics are complex protein structures derived from living organisms. Their development and regulation involves several key aspects not required for conventional drugs, including additional pre-clinical toxicology and manufacturing studies as well as special programs like orphan drug designation. The IND and BLA processes require comprehensive documentation of quality, safety and efficacy. After approval, biologics face ongoing post-market safety reporting and review of any manufacturing changes to ensure continued patient protection.
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.
This document provides an overview of biologics, their regulatory approval process in the United States and Europe, and differences between the two regions. It defines biologics as products derived from living organisms used to treat and prevent disease. The US Food and Drug Administration's Center for Biologics Evaluation and Research and the European Medicines Evaluation Agency regulate biologics. Companies must submit a Biological License Application in the US and a Marketing Authorization Application in Europe for product approval, which involves preclinical and clinical testing according to each region's guidelines. The main goal of regulations in both the US and Europe is to safeguard public health.
This document discusses biosimilar drugs. It begins by explaining that biosimilars are biologic medications that are highly similar to but not exact copies of an original biologic. It then discusses regulatory concerns around biosimilar development and approval including ensuring safety and effectiveness given potential immunogenicity issues. The document provides an overview of some biosimilars currently approved in other countries and areas of concern regarding biosimilar use such as interchangeability, pharmacovigilance, and naming.
This document summarizes information about biosimilars and the regulatory pathways for their approval in the United States and European Union. It discusses how biosimilars differ from traditional small-molecule generics due to biological molecules' larger size, greater complexity, and manufacturing dependence. The U.S. passed the Biologics Price Competition and Innovation Act in 2010 to create an approval pathway for follow-on biologics, requiring biosimilarity demonstration and possible interchangeability labeling. Upcoming FDA hearings will provide information to guide biosimilar approval requirements regarding analytical and clinical data needs. The E.U. has approved several biosimilars under its regulatory framework established in 2005.
Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and managing post-approval challenges.
This document summarizes guidelines for biosimilars in India. It begins by defining biosimilars as biologic compounds that are similar but not identical to reference biopharmaceuticals. It then discusses several biosimilar drugs used in cancer treatment such as G-CSF, interferons, and epoetins. While biosimilars have similar mechanisms of action, differences in manufacturing can result in differences in properties. The document concludes by outlining Indian regulatory guidelines for biosimilar approval and the importance of post-marketing safety monitoring to evaluate potential differences from reference drugs.
This document discusses biosimilars, which are biologic medications that are similar but not identical to an original biologic reference medication. It provides background on biosimilars and regulatory guidelines around them. Specifically, it notes that biosimilars take 6-9 years to develop compared to 3 years for generics, and that they require clinical trials to demonstrate safety and efficacy compared to the reference medication. The document also discusses biosimilar guidelines in India and examples of biosimilars used in cancer treatment, noting some differences between biosimilar versions of medications like G-CSF and interferons.
Biosimilars are biopharmaceutical drugs that are similar to an existing approved biologic drug (the reference product). Biosimilars undergo a step-wise comparability exercise to demonstrate similarity in structure, function, safety and efficacy to the reference product. Regulatory agencies such as the FDA and EMA require extensive characterization, non-clinical and clinical studies to establish biosimilarity. Guidelines for approval of biosimilars have been established in regions such as Europe, US, Korea, Singapore and India to enable a pathway for approval of biosimilar versions of biologic drugs.
Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #3 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
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 several important drug regulatory news and safety updates from regulatory authorities including Health Canada and the US FDA. It provides warnings and updates to healthcare professionals in Nepal about potential drug interactions and risks, including:
1) The risk of high anion gap metabolic acidosis with concomitant use of flucloxacillin and paracetamol.
2) The possible risk of hypothyroidism in infants given iodine-containing contrast agents.
3) The removal of a boxed warning about asthma deaths for medicines containing inhaled corticosteroids and long-acting beta agonists.
4) The rare risk of subacute cutaneous lupus erythematosus with proton
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Les organisateurs du Sommet sur la redéfinition des soins de santé par les patients, en partenariat avec le Comité consultatif autochtone, vous invitent à vous joindre à nous pour une discussion de six études de cas sur des médicaments oncologiques tels qu’analysés par un économiste de la santé sur la base des lignes directrices actuellement proposées par la Conseil d’examen du prix des médicaments brevetés (CEPMB). Seront présentés les résultats de l’étude et leurs implications sur l’accès aux médicaments. On discutera aussi de l’application possible de cette approche analytique à des domaines non oncologiques.
2 pmprb webinar april 7 2020 french hta and pmprb comparison chartNatalie Richardson
Les organisateurs du Sommet sur la redéfinition des soins de santé par les patients, en partenariat avec le Comité consultatif autochtone, vous invitent à vous joindre à nous pour une discussion de six études de cas sur des médicaments oncologiques tels qu’analysés par un économiste de la santé sur la base des lignes directrices actuellement proposées par la Conseil d’examen du prix des médicaments brevetés (CEPMB). Seront présentés les résultats de l’étude et leurs implications sur l’accès aux médicaments. On discutera aussi de l’application possible de cette approche analytique à des domaines non oncologiques.
3 pmprb webinar april 7 2020 french guidelines case studies matthew broughamNatalie Richardson
Les organisateurs du Sommet sur la redéfinition des soins de santé par les patients, en partenariat avec le Comité consultatif autochtone, vous invitent à vous joindre à nous pour une discussion de six études de cas sur des médicaments oncologiques tels qu’analysés par un économiste de la santé sur la base des lignes directrices actuellement proposées par la Conseil d’examen du prix des médicaments brevetés (CEPMB). Seront présentés les résultats de l’étude et leurs implications sur l’accès aux médicaments. On discutera aussi de l’application possible de cette approche analytique à des domaines non oncologiques.
Les organisateurs du Sommet sur la redéfinition des soins de santé par les patients, en partenariat avec le Comité consultatif autochtone, vous invitent à vous joindre à nous pour une discussion de six études de cas sur des médicaments oncologiques tels qu’analysés par un économiste de la santé sur la base des lignes directrices actuellement proposées par la Conseil d’examen du prix des médicaments brevetés (CEPMB). Seront présentés les résultats de l’étude et leurs implications sur l’accès aux médicaments. On discutera aussi de l’application possible de cette approche analytique à des domaines non oncologiques.
4 pmprb webinar recommendations louise binder april 7 2020Natalie Richardson
The Patients Redefining Healthcare Summit co-hosts, in partnership with the Indigenous Advisory Committee, invite you to join us as we discuss six case studies of oncology drugs analyzed by a health economist based on the proposed PMPRB guidelines. The results and the implications for accessing drugs will be presented. Potential application of this analytical approach in non-oncology areas will also be discussed. Webinar recording available on Save Your Skin Foundation youTube channel.
3 pmprb guidelines case studies presentation april 7 2020 mbNatalie Richardson
This document analyzes how several new oncology drugs recently approved in Canada would fare under the proposed new PMPRB guidelines. It estimates the maximum rebated price (MRP) that each drug could expect to receive and whether the drug would still launch in Canada at that price. Drugs like venetoclax, daratumumab, blinatumomab and osimertinib would likely require price reductions of over 80% to reach the MRP, making their availability in Canada very unlikely. Nivolumab and dinutuximab could launch with smaller price adjustments of 25% or less. The analysis identifies assumptions made and limitations in using CADTH reports to fully estimate prices under the new guidelines.
2 chart - hta and pmprb comparison april 7 2020 webinarNatalie Richardson
Chart created by: Louise Binder & Antonella Scali
The Patients Redefining Healthcare Summit co-hosts, in partnership with the Indigenous Advisory Committee, invite you to join us as we discuss six case studies of oncology drugs analyzed by a health economist based on the proposed PMPRB guidelines. The results and the implications for accessing drugs will be presented. Potential application of this analytical approach in non-oncology areas will also be discussed.
This document summarizes a webinar about proposed reforms to the Patented Medicine Prices Review Board (PMPRB) in Canada. The key points are:
1) The PMPRB regulates drug prices to ensure they are not excessive but reforms aim to make it more "relevant" and lower prices by 20%.
2) New proposals would expand the international drug price comparator countries to include lower-cost nations and add new "economic" pricing factors.
3) There is concern the reforms could discourage drug launches in Canada and clinical trials due to greater price uncertainty and the risk of much lower allowed prices.
Merkel Cell Carcinoma: From Diagnosis to Treatment (webinar)Natalie Richardson
This document provides an overview of Merkel cell carcinoma, including its histogenesis, pathogenesis, epidemiology, clinical features, diagnosis, staging, treatment options for both localized and metastatic disease, and prognosis. Key points discussed are the role of Merkel cell polyomavirus in pathogenesis, increasing incidence with age and sun exposure, diagnosis through biopsy and immunohistochemistry, standard treatment involving surgery and/or radiation for localized disease and chemotherapy or immunotherapy for advanced stages, and generally poor prognosis especially for metastatic or recurrent disease.
Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #2 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Hiranandani Hospital in Powai, Mumbai, is a premier healthcare institution that has been serving the community with exceptional medical care since its establishment. As a part of the renowned Hiranandani Group, the hospital is committed to delivering world-class healthcare services across a wide range of specialties, including kidney transplantation. With its state-of-the-art facilities, advanced medical technology, and a team of highly skilled healthcare professionals, Hiranandani Hospital has earned a reputation as a trusted name in the healthcare industry. The hospital's patient-centric approach, coupled with its focus on innovation and excellence, ensures that patients receive the highest standard of care in a compassionate and supportive environment.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Cell Therapy Expansion and Challenges in Autoimmune Disease
Biosimilars Presentation - Health Canada
1. About Biosimilars:
What we know and what we want to know
Save your Skin Foundation Webinar
January 19, 2018
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
2. Outline
• What are biologics and biosimilars ?
• How are biosimilars regulated by Health Canada?
• Questions about biosimilars from a regulator’s perspective
• What’s Next?
– Key Health Canada activities related to biosimilars
2
3. What are biologics and biosimilars?
Biologic drugs
• Derived from metabolic activity of living organisms.
• Large, structurally complex and difficult to characterize , and inherently more
variable
• Sensitive to light, temperature and susceptible to contamination
• Differences between small molecule drugs and biologics require differences in
regulatory requirements – strong regulatory oversight
Biosimilars
• A biosimilar is a biologic drug that enters the market subsequent to a version
previously authorized in Canada, and has demonstrated similarity to a reference
biologic drug (originator)
• The demonstration of similarity enables the sponsor to rely on relevant publicly
available information (safety and efficacy) about the reference biologic drug
• Submissions currently under review for oncology biosimilars for TRASTUZUMAB ,
RITUXIMAB, BEVACIZUMAB
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4. How are biosimilars regulated by Health Canada?
• Biosimilars are regulated as new drugs in Canada; they are subject to
the Food and Drugs Act and the Food and Drug Regulations just like
other new biologic drugs
• Flexibility under existing framework allows for the regulation of
biosimilars using the concept of similarity
• The same regulatory controls and post-market surveillance
requirements apply
4
5. Questions about biosimilars from a
regulatory perspective
1. How do the development
and regulatory review
processes for innovators and
biosimilars differ?
2. Why are “traditional” clinical
studies not needed in each
indication?
3. Are biosimilars as safe and
effective as the originator
products?
4. How does Health Canada
align internationally?
5. What is Health Canada’s
position on switching and
interchangeability?
5
6. 1. How do the development and regulatory review
processes for innovator products and biosimilars differ?
Innovator Product
-Sponsor must independently
demonstrate the quality, safety
and efficacy of a therapeutic
product.
Biosimilar
-Biosimilar sponsor must
demonstrate similarity and
that there are no clinically
meaningful differences
between the biosimilar and
innovator product
-Step-wise approach with
quality comparability as the
foundation
6Accessed at: http://www.health.gov.au
7. 2. Why are “traditional” clinical studies not required in
each indication?
The innovator has established efficacy and safety for each indication.
A biosimilar does not have to re-establish the de novo benefit/risk
Since a biosimilar is very similar in structure and function to a reference biologic drug with
well-established safety and efficacy, clinical studies do not need to be repeated for each
indication.
The purpose of the clinical program is to show that residual uncertainty from
the quality assessment does not cause clinically meaningful differences in
efficacy, safety and/or immunogenicity in a sensitive population.
A biosimilar sponsor is eligible to apply for the indication(s) and condition(s)
of use that are held by the reference biologic drug authorized in Canada
based on the totality of evidence obtained from all comparative analyses.
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8. 3. Are biosimilars as safe & effective as the originator?
Patients can be confident that a biosimilar will work the same as
its reference drug
When Health Canada approves a biosimilar:
The quality, safety and efficacy of the biosimilar are highly similar
to the reference biologic drug
There are no clinically meaningful differences between the
biosimilar and the reference biologic drug
Patients and healthcare professionals can have the same
confidence in the quality, safety and efficacy as any other biologic
drug
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9. 4. How does Health Canada align internationally?
• Health Canada’s regulatory framework for biosimilars was largely
modelled after Europe’s framework
• Health Canada experts regularly interact with those from other
regulatory agencies – to promote regulatory alignment and
information-sharing
Regular Biosimilar Cluster teleconferences (FDA-EMA-Japan-Canada)
WHO – biosimilar guideline drafting groups
International Pharmaceutical Regulators Forum (IPRF) Biosimilars Working Group
Large group of regulatory authorities
Health Canada has just taken on the role of co-chair of this group
New group being formed with regulators from Australia, Canada,
Singapore, Switzerland (ACSS)
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10. 5. What is Health Canada’s position on switching and
interchangeability?
10
Health Canada Europe EMA US FDA
• Health Canada's
authorization of a
biosimilar is not a
declaration of
equivalence to the
reference biologic drug
• The authority to declare
two products
interchangeable rests
with each province and
territory
• Authorization by the
EMA does not include a
recommendation on
interchangeability
• Substitution policies
vary between member
states
• Interchangeable
designation and
standards are mandated
by law
• Draft guidance
published by FDA in Jan.
2017
• No interchangeable
biosimilar products
licenced to date
11. What’s Next?
Biologics Naming
• Calls for a naming convention that distinguishes between biologic drugs that share the
same common name to facilitate accurate prescribing, dispensing and surveillance
• Differing approaches internationally
• Consultation launched January 18th to help inform development of a Canadian policy
https://www.ismp-canada.org/biosimilars/consultation.html
https://www.ismpcanada.org/fr/biologiques/consultation.html
Stakeholder outreach and education
• Health Canada is exploring a series of webinars on biosimilars
• Comments, questions, ideas are welcome
Capacity building and information sharing
• Hiring new review staff to respond to increase in number of biosimilar submissions
• Implementing tools to facilitate information-sharing with partners, such as Health
Technology Assessment Bodies
11
12. Contact information:
Stephanie Hardy
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Stephanie.hardy@canada.ca
Cathy Parker
Director General
Biologics and Genetic Therapies Directorate
Cathy.parker@canada.ca
Health Canada Biosimilars webpage
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/biosimilars-biosimilaires-index-eng.php
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13. Authorized Biosimilars - as of January 2018
Biosimilar Reference
Biologic Drug
Therapeutic area Date of NOC
Omnitrope
(Somatropin – Human
Growth Hormone)
Genotropin Growth Hormone Deficiency in Children and
Adult Growth Hormone Deficiency
April 20, 2009
Omnitrope Genotropin Additional indications for Small for
Gestational Age, Idiopathic Short Stature and
Turner Syndrome
May 8, 2015
Inflectra
(Infliximab –Monoclonal
Antibody)
Remicade Rheumatoid Arthritis, Ankylosing Spondylitis,
Psoriatic Arthritis and Plaque Psoriasis
January 15, 2014
Inflectra Remicade Additional indications for Adult Crohn's
disease, including fistulising Crohn's disease
and adult ulcerative colitis
June 10, 2016
Remsima
(Infliximab – Monoclonal
Antibody)
Remicade Rheumatoid Arthritis, Ankylosing Spondylitis,
Psoriatic Arthritis and Plaque Psoriasis
January 15, 2014
Remsima Remicade Additional indications for Adult Crohn's
disease, including fistulising Crohn's disease
and adult ulcerative colitis
August 5, 2016
Basaglar
(Insulin Glargine -
Recombinant Human
Insulin Analogue)
Lantus Treatment of pediatric (>6 years) and adult
patients with Type 1 diabetes mellitus, and
adult patients with type 2 diabetes mellitus
September 1, 2015
Grastofil (filgrastim) Neupogen Prevention or treatment of neutropenia December 7, 2015
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14. Biosimilar Reference
Biologic Drug
Therapeutic area Date of NOC
Brenzys (entanercept) Enbrel Rheumatoid Arthritis and Ankylosing
Spondylitis
August 31, 2016
Erelzi (entanercept) Enbrel Rheumatoid Arthritis, Polyarticular
Juvenile Idiopathic Arthritis and
Ankylosing Spondylitis
April 6, 2017
Renflexis (Infliximab) Remicade Rheumatoid arthritis, Ankylosing
Spondylitis, Psoriatic arthritis, Plaque
Psoriasis, Adult Crohn’s disease,
including fistulising Crohn’s disease and
adult ulcerative colitis
December 1, 2017
Admelog (insulin lispro) Humalog Treatment of patients with diabetes
mellitus.
November 16, 2017
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