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.
Biosimilars are biologic medicines that are developed to be similar to existing approved biologic medicines known as reference medicines. Biosimilars must demonstrate similarity to the reference medicine in terms of quality, safety and efficacy through comprehensive testing and analysis. While biosimilars may provide reduced costs and increased access to biologic treatments, they are more complex than traditional small molecule drugs due to differences in size, structure, manufacturing processes, and potential for immunogenicity. Thorough evaluation and regulation is required to ensure biosimilars are interchangeable for the reference product without compromising patient safety.
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
This document discusses biosimilar drugs. It begins by defining biological products and biosimilars. Biosimilars are biologics that are similar but not identical to an already approved biologic reference product. They are developed to be similar in safety, purity and potency. Key differences between biosimilars and generics are discussed. For approval, biosimilars require clinical trials and other testing to show similarity rather than equivalence. Switching a patient from a reference biologic to a biosimilar requires physician approval due to unknown effects on immunogenicity. Naming of biosimilars and increasing competition in the biologics market are also covered.
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 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.
The document discusses biosimilars, which are biologic medicines that are similar but not identical to an original biologic. It describes the complex multi-step process used to develop and test biosimilars. This includes characterizing the original biologic, developing a unique cell line and process, testing for similarity through analytical and non-clinical studies, and clinical trials. Regulatory agencies oversee biosimilars differently than generics due to concerns over safety, substitution, naming, and labeling of the non-identical products.
This document discusses biosimilars and their regulation. It begins by defining biotechnology and biopharmaceuticals. Biosimilars are described as legally approved versions of biologic drugs that are similar but not identical to the original version. The document notes challenges in developing biosimilars due to the complex nature of biologics compared to traditional small molecule drugs. It also discusses concerns regarding efficacy, safety and interchangeability of biosimilars. Finally, it provides an overview of regulatory frameworks for biosimilars in the US, EU and India.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Biosimilars are biologic medicines that are developed to be similar to existing approved biologic medicines known as reference medicines. Biosimilars must demonstrate similarity to the reference medicine in terms of quality, safety and efficacy through comprehensive testing and analysis. While biosimilars may provide reduced costs and increased access to biologic treatments, they are more complex than traditional small molecule drugs due to differences in size, structure, manufacturing processes, and potential for immunogenicity. Thorough evaluation and regulation is required to ensure biosimilars are interchangeable for the reference product without compromising patient safety.
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
This document discusses biosimilar drugs. It begins by defining biological products and biosimilars. Biosimilars are biologics that are similar but not identical to an already approved biologic reference product. They are developed to be similar in safety, purity and potency. Key differences between biosimilars and generics are discussed. For approval, biosimilars require clinical trials and other testing to show similarity rather than equivalence. Switching a patient from a reference biologic to a biosimilar requires physician approval due to unknown effects on immunogenicity. Naming of biosimilars and increasing competition in the biologics market are also covered.
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 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.
The document discusses biosimilars, which are biologic medicines that are similar but not identical to an original biologic. It describes the complex multi-step process used to develop and test biosimilars. This includes characterizing the original biologic, developing a unique cell line and process, testing for similarity through analytical and non-clinical studies, and clinical trials. Regulatory agencies oversee biosimilars differently than generics due to concerns over safety, substitution, naming, and labeling of the non-identical products.
This document discusses biosimilars and their regulation. It begins by defining biotechnology and biopharmaceuticals. Biosimilars are described as legally approved versions of biologic drugs that are similar but not identical to the original version. The document notes challenges in developing biosimilars due to the complex nature of biologics compared to traditional small molecule drugs. It also discusses concerns regarding efficacy, safety and interchangeability of biosimilars. Finally, it provides an overview of regulatory frameworks for biosimilars in the US, EU and India.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Target identification, target validation, lead identification and lead
Optimization.
• Economics of drug discovery.
• Target Discovery and validation-Role of Genomics, Proteomics and
Bioinformatics.
• Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins.
• Role of transgenic animals in target validation.
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.
- 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.
Target Validation
Introduction,Drug discovery, Target identification and validation, Target validation and techniques
By
Ms. B. Mary Vishali
Department of Pharmacology
Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
Pharmacogenomics is the study of how genetic factors influence individual responses to drugs. It aims to develop personalized drug therapies tailored to an individual's genetics. This could increase drug effectiveness to nearly 100% while decreasing side effects significantly by identifying genetic reasons for variances in drug response. However, barriers remain such as complexity in finding gene variations and limited drug alternatives. Overall, pharmacogenomics promises more rational drug development and safer, more accurate individualized treatment but overcoming challenges will require multidisciplinary efforts.
High Throughput Screening (HTS) involves the automated screening of large libraries of chemical compounds against biological targets at a rapid pace. HTS uses robotics, miniaturization, and automation to screen 50,000-100,000 compounds per week. The goals of HTS are to identify compounds that selectively bind and modulate biological targets of interest. Hits identified through primary screening are then evaluated further through secondary assays, SAR analysis, and in vitro/in vivo studies. HTS accelerates drug discovery by allowing for the rapid evaluation of large compound libraries.
Genomics and proteomics in drug discovery and developmentSuchittaU
This document discusses the role of genomics and proteomics in drug discovery and development. It explains that genomics and proteomics technologies can help identify new drug targets by comparing gene and protein expression between healthy and diseased cells. Proteomics in particular analyzes changes in protein levels and can quantify individual proteins using techniques like 2D gel electrophoresis and mass spectrometry. The integration of genomics and proteomics provides a more comprehensive understanding of biological systems and is improving the drug discovery process.
OVERVIEW OF MODERN DRUG DISCOVERY PROCESSSweety gupta
The document provides an overview of the modern drug discovery process, which involves 5 main steps:
1) Target identification and validation to find the molecular structures involved in the disease.
2) Hit identification and validation to find small molecule leads that have the desired effect on the targets.
3) Moving from a hit to a lead by refining hits into more selective compounds.
4) Lead optimization to improve properties and address any deficiencies while maintaining desired effects.
5) Late lead optimization to further assess safety before clinical trials.
Modern drug discovery is an expensive process that can cost over $1 billion on average due to large investments required. Bioinformatics and genomic/proteomic technologies help accelerate the process and reduce
Pharmacogenomics refers to the study of the relationship between specific DNA-sequence variation and drug effect, for example, variation in haplotype versus variation in therapeutic outcome
This document describes the methods for conducting an in vitro chromosomal aberration test. White blood cells are cultured from human donors and exposed to test substances like cyclophosphamide. Cells are harvested at different timepoints throughout the cell cycle. Slides are prepared, stained, and analyzed under a microscope to identify chromosomal abnormalities like deletions, duplications, inversions, and translocations. Acceptance criteria include having homogenous results between replicates, aberration frequencies within historical controls, and a concentration-dependent response to a test substance. A conclusion on the potential of a substance to induce chromosomal aberrations is based on statistical analyses.
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
The document discusses pharmacogenomics and how genetic variations can affect individual responses to drugs. It describes how pharmacogenomics examines genomic loci and biological pathways to determine drug variability. It also discusses pharmacogenetics which focuses on single gene variants. The document outlines some merits of pharmacogenomics like improving drug safety and personalized treatment. It then discusses various scenarios on how genetic polymorphisms can impact different drug metabolism pathways. Finally, it examines how specific genetic variations in drug metabolizing enzymes and transporters can influence drug pharmacokinetics and potential adverse effects.
Combinatorial chemistry and high throughput screeningAnji Reddy
Combinatorial chemistry and high-throughput screening techniques allow for the rapid synthesis and testing of large libraries of compounds. Combinatorial chemistry uses solid and solution phase methods to efficiently produce thousands of compounds, while high-throughput screening employs automated instrumentation like microtiter plates to quickly assess large numbers of compounds through functional or non-functional assays. These approaches provide advantages for drug discovery by facilitating the identification of hit compounds for further optimization into drug leads.
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.
1. The document discusses hERG safety assays, which evaluate a compound's potential to block the hERG potassium channel and cause cardiac toxicity.
2. It describes several methods for conducting hERG safety assays, including the automated QPatch HT system, conventional whole-cell patch clamp, and fluorescent flux-based assays.
3. The automated patch clamp system allows for higher throughput screening with better consistency than conventional patch clamp, and fluorescent flux assays can achieve very high throughput in 96-well or 384-well formats.
This document summarizes a seminar on safety pharmacology. It defines safety pharmacology and outlines the core battery of studies, which evaluate effects on the central nervous, cardiovascular and respiratory systems. It describes when safety pharmacology studies are needed at different stages of drug development and under various conditions. Guidelines for conducting the studies from organizations like ICH are also discussed.
Genomics, proteomics, and bioinformatics are important fields that help advance drug development. Genomics studies entire genomes and can identify disease-associated genes. Proteomics identifies the proteins expressed in a sample and how they differ between healthy and diseased tissues. Bioinformatics uses computers to store and analyze biochemical and biological data, especially related to genomics. These fields help discover new drug targets, validate existing targets, select drug candidates, study mechanisms of action and toxicity. Integrating omics data from genomics to proteomics provides a more comprehensive understanding of biological systems compared to individual fields alone.
This document discusses genetic polymorphisms in drug transport proteins and how they can impact drug pharmacokinetics and toxicity. It introduces two major superfamilies of transport proteins - ATP-binding cassette (ABC) transporters and solute carrier (SLC) proteins. Specific ABC transporters discussed include P-glycoprotein (ABCB1), the multidrug resistance proteins ABCC1 and ABCG2. The document also summarizes key SLC transporters and provides examples of important substrates for each. Genetic variations in these transport proteins can significantly influence individual responses to drugs like irinotecan used in cancer chemotherapy.
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.
Biologicals and biosimilars are complex drugs produced by living cells. Biosimilars are similar but not identical copies of biological reference drugs. Regulatory requirements for biosimilars are more extensive than generics but less so than original biological drugs. Biosimilars require comparative quality analysis, limited clinical trials and toxicity studies against the reference drug. Due to inherent structural differences, biosimilars cannot be considered interchangeable with the reference drug.
Target identification, target validation, lead identification and lead
Optimization.
• Economics of drug discovery.
• Target Discovery and validation-Role of Genomics, Proteomics and
Bioinformatics.
• Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins.
• Role of transgenic animals in target validation.
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.
- 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.
Target Validation
Introduction,Drug discovery, Target identification and validation, Target validation and techniques
By
Ms. B. Mary Vishali
Department of Pharmacology
Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
Pharmacogenomics is the study of how genetic factors influence individual responses to drugs. It aims to develop personalized drug therapies tailored to an individual's genetics. This could increase drug effectiveness to nearly 100% while decreasing side effects significantly by identifying genetic reasons for variances in drug response. However, barriers remain such as complexity in finding gene variations and limited drug alternatives. Overall, pharmacogenomics promises more rational drug development and safer, more accurate individualized treatment but overcoming challenges will require multidisciplinary efforts.
High Throughput Screening (HTS) involves the automated screening of large libraries of chemical compounds against biological targets at a rapid pace. HTS uses robotics, miniaturization, and automation to screen 50,000-100,000 compounds per week. The goals of HTS are to identify compounds that selectively bind and modulate biological targets of interest. Hits identified through primary screening are then evaluated further through secondary assays, SAR analysis, and in vitro/in vivo studies. HTS accelerates drug discovery by allowing for the rapid evaluation of large compound libraries.
Genomics and proteomics in drug discovery and developmentSuchittaU
This document discusses the role of genomics and proteomics in drug discovery and development. It explains that genomics and proteomics technologies can help identify new drug targets by comparing gene and protein expression between healthy and diseased cells. Proteomics in particular analyzes changes in protein levels and can quantify individual proteins using techniques like 2D gel electrophoresis and mass spectrometry. The integration of genomics and proteomics provides a more comprehensive understanding of biological systems and is improving the drug discovery process.
OVERVIEW OF MODERN DRUG DISCOVERY PROCESSSweety gupta
The document provides an overview of the modern drug discovery process, which involves 5 main steps:
1) Target identification and validation to find the molecular structures involved in the disease.
2) Hit identification and validation to find small molecule leads that have the desired effect on the targets.
3) Moving from a hit to a lead by refining hits into more selective compounds.
4) Lead optimization to improve properties and address any deficiencies while maintaining desired effects.
5) Late lead optimization to further assess safety before clinical trials.
Modern drug discovery is an expensive process that can cost over $1 billion on average due to large investments required. Bioinformatics and genomic/proteomic technologies help accelerate the process and reduce
Pharmacogenomics refers to the study of the relationship between specific DNA-sequence variation and drug effect, for example, variation in haplotype versus variation in therapeutic outcome
This document describes the methods for conducting an in vitro chromosomal aberration test. White blood cells are cultured from human donors and exposed to test substances like cyclophosphamide. Cells are harvested at different timepoints throughout the cell cycle. Slides are prepared, stained, and analyzed under a microscope to identify chromosomal abnormalities like deletions, duplications, inversions, and translocations. Acceptance criteria include having homogenous results between replicates, aberration frequencies within historical controls, and a concentration-dependent response to a test substance. A conclusion on the potential of a substance to induce chromosomal aberrations is based on statistical analyses.
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
The document discusses pharmacogenomics and how genetic variations can affect individual responses to drugs. It describes how pharmacogenomics examines genomic loci and biological pathways to determine drug variability. It also discusses pharmacogenetics which focuses on single gene variants. The document outlines some merits of pharmacogenomics like improving drug safety and personalized treatment. It then discusses various scenarios on how genetic polymorphisms can impact different drug metabolism pathways. Finally, it examines how specific genetic variations in drug metabolizing enzymes and transporters can influence drug pharmacokinetics and potential adverse effects.
Combinatorial chemistry and high throughput screeningAnji Reddy
Combinatorial chemistry and high-throughput screening techniques allow for the rapid synthesis and testing of large libraries of compounds. Combinatorial chemistry uses solid and solution phase methods to efficiently produce thousands of compounds, while high-throughput screening employs automated instrumentation like microtiter plates to quickly assess large numbers of compounds through functional or non-functional assays. These approaches provide advantages for drug discovery by facilitating the identification of hit compounds for further optimization into drug leads.
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.
1. The document discusses hERG safety assays, which evaluate a compound's potential to block the hERG potassium channel and cause cardiac toxicity.
2. It describes several methods for conducting hERG safety assays, including the automated QPatch HT system, conventional whole-cell patch clamp, and fluorescent flux-based assays.
3. The automated patch clamp system allows for higher throughput screening with better consistency than conventional patch clamp, and fluorescent flux assays can achieve very high throughput in 96-well or 384-well formats.
This document summarizes a seminar on safety pharmacology. It defines safety pharmacology and outlines the core battery of studies, which evaluate effects on the central nervous, cardiovascular and respiratory systems. It describes when safety pharmacology studies are needed at different stages of drug development and under various conditions. Guidelines for conducting the studies from organizations like ICH are also discussed.
Genomics, proteomics, and bioinformatics are important fields that help advance drug development. Genomics studies entire genomes and can identify disease-associated genes. Proteomics identifies the proteins expressed in a sample and how they differ between healthy and diseased tissues. Bioinformatics uses computers to store and analyze biochemical and biological data, especially related to genomics. These fields help discover new drug targets, validate existing targets, select drug candidates, study mechanisms of action and toxicity. Integrating omics data from genomics to proteomics provides a more comprehensive understanding of biological systems compared to individual fields alone.
This document discusses genetic polymorphisms in drug transport proteins and how they can impact drug pharmacokinetics and toxicity. It introduces two major superfamilies of transport proteins - ATP-binding cassette (ABC) transporters and solute carrier (SLC) proteins. Specific ABC transporters discussed include P-glycoprotein (ABCB1), the multidrug resistance proteins ABCC1 and ABCG2. The document also summarizes key SLC transporters and provides examples of important substrates for each. Genetic variations in these transport proteins can significantly influence individual responses to drugs like irinotecan used in cancer chemotherapy.
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.
Biologicals and biosimilars are complex drugs produced by living cells. Biosimilars are similar but not identical copies of biological reference drugs. Regulatory requirements for biosimilars are more extensive than generics but less so than original biological drugs. Biosimilars require comparative quality analysis, limited clinical trials and toxicity studies against the reference drug. Due to inherent structural differences, biosimilars cannot be considered interchangeable with the reference drug.
Biosimilars are biological drugs that are similar to already approved biologic reference drugs. They are produced through biotechnology methods involving genetic engineering. While biosimilars hold promise to increase access to biologic treatments, they differ from traditional generics in important ways due to the complex nature of biologics. Biosimilars must undergo rigorous testing and demonstration of similarity to the reference product to ensure similar safety and efficacy profiles. Regulatory frameworks for approving biosimilars have been established by the EMA and FDA, with guidelines outlining requirements for comprehensive characterization, clinical trials, and pharmacovigilance to ensure patient safety.
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 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.
Biosimilars are biologic medicines that are similar to already approved biologic reference products, though due to structural complexities they are not generic equivalents. They must demonstrate similarity in terms of safety, purity and potency through comprehensive comparability studies. Biologics are large, complex molecules produced through biotechnology in living cells, whereas generics are identical small molecule chemicals. Due to minor manufacturing differences, biosimilars can have efficacy or immunogenicity issues not seen with generics. India regulates biosimilars through various agencies including the Central Drugs Standard Control Organization.
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.
Biological agents and it role in current era and future roleHarsh shaH
This document discusses biological agents and their role in medicine. It defines biological products and biosimilars, and describes how biosimilars differ from original biologics in their manufacturing process and ability to be replicated exactly. The document outlines regulatory guidelines for biosimilars from agencies like EMA and FDA. Biosimilars can expand access to biologic treatments for diseases like rheumatoid arthritis and have potential cost savings compared to originator biologics. Safety monitoring is important due to concerns like immunogenicity.
The present slide focuses on the applications and different uses of biosimilars along with the basic difference in between biosimilars and bioequivalence.
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.
Generic biologics, also known as biosimilars, are versions of original biologic drugs that contain the same active ingredients. Biosimilars are developed to be highly similar to an existing FDA-approved biologic, known as the reference product, with no clinically meaningful differences in terms of safety and effectiveness. Biological products are large, complex molecules that are often difficult to characterize compared to small molecule drugs. Special considerations are needed in assessing bioavailability and bioequivalence for biosimilars due to potential high variability between subjects.
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.
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 generics and biosimilars. It provides background on the Hatch-Waxman Act which established the abbreviated new drug application process for generic small molecule drugs. It also discusses the Biologics Price Competition and Innovation Act which created an abbreviated licensure pathway for biosimilar biologics. The manufacturing of biologics is more complex than small molecules due to production in living cells, and biosimilars are highly similar but not identical copies. Clinical trials are required to demonstrate biosimilarity in terms of safety and efficacy.
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.
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
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
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.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
1. Pharmacology
M.Pharm Sem_1
Cellular & Molecular Pharmacology 104T
Prepared by : Pal Rohit
Roll no: 47
BIOSIMILARS
K.B Institute of Pharmaceutical Education & Research
2. TABLE
OF
CONTENTS
Introduction to Biologics
Introduction to Biosimilars
Definitions
Principles for development of Biosimilars
Difference from Generics
Production of Biopharmaceutical
Manufacturing issues with Biosimilar
Concerns with Biosimilars
Role of Pharmacovigilance
Benefits of Biosimilars
3. INTRODUCTION TO BIOLOGICS
• A biologic, also known as a biologic medical product, or biopharmaceutical, is any
pharmaceutical drug product manufactured in, extracted from, or semisynthesized from
biological sources and used in treatment or prevention of disease.
• Biologic medicines generally made by using biotechnological methods like Recombinant DNA
technology, PCR, gene delivery ,genome editing (CRISPR).
• Biologics compared to the synthetic chemical molecules are 100 to 1000 times larger in size,
having several hundred amino acid and biochemically joined together in a defined sequence by
peptide bonds to form a polypeptide. Thus, structurally, biologics are more complex than low
molecular weight drugs.
• Ultimately biologics are proteins and due to the bigger size and high molecular weight (average
molecular weight of 150 Dalton per amino acid) it cannot cross BBB and also cannot pass
through stomach wall so ,biopharmaceuticals can be only given through parenteral route.
5. INTRODUCTION TO BIOSIMILAR
• Biosimilars are the subsequent version of biologic medical products where patent protection
and marketing exclusivity have expired where they are authorized on the basis of similarity in
terms of quality , non-clinical and clinical parameters between biosimilar and reference
biologics.
• Unlike generics where the active components are completely identical biosimilars are not likely
to be completely identical.
• Because of structural & manufacturing complexities these biological products are
considered as similar but not generics equivalent of innovator biopharmaceuticals.
• The quality , safety and efficacy of a biosimilar product must be approved by relevant regulatory
body before marketing. So the different regulatory bodies have different definition for
biosimilars.
6. DEFINITIONS
• WHO :- A biotherapeutic product which is similar in terms of quality, safety and efficacy
to an already licensed reference biotherapeutic product.
• US-FDA :-A biosimilar is a biological product that is highly similar to a US-licensed
reference biological product notwithstanding minor differences in clinically inactive
components, and for which there are no clinically meaningful differences between the
biological product and the reference product in terms of the safety, purity, and potency of
the product.
• EMEA :-A biosimilar is a biological medicine highly similar to another already approved
biological medicine (the 'reference medicine'). Biosimilars are approved according to the
same standards of pharmaceutical quality, safety and efficacy that apply to all biological
medicines
7. The similarities among these regulatory agencies’ definition of a biosimilar can be distilled into two
main themes:
1. Biosimilars are not generics and are copies of already approved products that have proven
to be similar to the original product (i.e., reference product)
2. Biosimilars must possess similarity in quality, safety and efficacy to an approved biologic
product.
• However, the process of introducing a biosimilar to an innovator product is far more complex than
the relatively straightforward process of introducing a generic equivalent to an innovator product
based on a new chemical entity.
• the active substance of a biopharmaceuticals is large complex protein structures not a
single molecular entity that’s why active component in two products are highly unlikely to
be identical therefor unlike generics biosimilars are only similar not identical.
• In this way, biosimilars are "similar but not the same" or in other words biosimilars are "the twin
but not the clone" to the original biologic innovator product.
8. PRINCIPLES FOR DEVELOPMENT OF
BIOSIMILARS
• Developed through sequential process.
• Extensive comparative studies between reference drug and drug under development.
• Extent of testing of biosimilar is less than that of reference product.
• Product should meet acceptable levels of safety ,efficacy and quality with the
reference drug.
11. 1ST APPROVED BIOSIMILARS
• India :- Biovac™ (hepatitis B vaccine, Wockhardt) in year 2000.
Use as vaccine for hepatitis B.
• USA :- Zarxio® (filgrastim, Sandoz Inc.) in March 2015.
Use to increase the neutrophils count in treatment of cancer or HIV.
• EUROPE :- Omnitrope® (somatropin, Sandoz Inc.) in 2006.
Use as a substitute of human growth hormone .
12. ISSUES WITH MANUFACTURING BIOSIMILARS.
• Biosimilars are the large complex protein molecules so variability in or changes to any step
of the manufacturing process for a biologic or differences between the manufacturing
processes for an originator and biosimilar can substantially impact the physicochemical and
functional properties of a biologic product.
• Most biological substances are labile and sensitive to heat, oxidation, and sometimes light.
Subtle differences in their manufacturing process may affect their quality attributes with a
possible impact on the safety and efficacy prole of the medicinal product.
• Apparently biosimilars are a biologic product so no. Of starting and raw material
are biological origin so their manufacturing process is conducted under mild physiological
conditions of temperature, pH, ionic strength, and so on and that their chemical nature (i.e.,
proteins, glycoproteins, polysaccharides) may support microbial growth.
13. • biologics thus pose a higher risk of contamination by micro-organisms, viruses, and
nonconventional infectious agents as compared to chemical drugs.
• That kind risk cannot be mitigated by a terminal sterilization step, which is not applicable to
heat labile substances.
• most biological substances cannot be administered orally without being digested. As a
consequence, biological medicinal products are mainly parenteral forms. Parenterally
administered medicinal products need to be sterile and free of pyrogens.
• Another particular feature of biologics comes from their capacity to raise an immune
response. Setting aside vaccines, such a response is not desirable since it can elicit the
production of antibodies that may neutralize the biological active substance or can induce
severe side effects by neutralizing endogenous factors.
15. IMMUNOGENICITY
• Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an
immune response in the body of a human or other animal.
• Like all biologics, biosimilars are structurally complex proteins that are typically
manufactured using genetically engineered animal, bacterial or plant cell culture systems.
• When administered to patients, all therapeutic proteins have the potential to induce an
unwanted immune response (i.e., to stimulate the formation of antidrug antibodies [ADAs])
• The impact of immune responses can range from no apparent effect to changes in
pharmacokinetics (PK), loss of effect and serious adverse events.
• The best ex for this is Pure red cell aplasia (PRCA) caused by biosimilar of Epoetin alfa.
16. EPOETIN ALFA
• The concern regarding immunogenicity is highlighted by the increase in number of cases of
pure red cell aplasia associated with a specific formulation of epoetin alfa.
• In this there was increase in the number of cases of pure red cell aplasia associated with a
specific formulation of epoetin alfa.
• Pure red cell aplasia : PRCA refers to a type of anaemia affecting the precursors to red
blood cells but not to white blood cells. In PRCA, the bone marrow ceases to
produce red blood cells.
• In most patients who were treated with EPREX biosimilar of Epoetin alfa there
were production of neutralizing antibodies against endogenous epoetin which supressed
the production of RBC in the bone marrow.
17. • Most of the cases were noted outside the U.S.
• The most likely cause was subtle changes in the manufacturing process. In the formulation
Eprex, the human albumin stabilizer was replaced by polysorbate 80 and glycine.
• Polysorbate 80 is supposed to have increased the immunogenicity of Eprex by eliciting the
formation of epoetin-containing micelles or by interacting with leachates released by the
uncoated rubber stoppers of prefilled syringes.
18. EFFICACY ISSUES
• Studies done in the past have demonstrated the differences between the bioactivity of the
biosimilars and their innovator products.
• In a study comparing 11 epoetin alfa products from four different countries (Korea,
Argentina, China, India), the isoform distribution among these products was variable and
there were significant diversions from specification for in vivo bioactivity.
• For example, in vivo bioactivity ranged from 71 to 226%, with 5 products failing to fulfill their
own specification.
• in case of monoclonal antibody therapy or treating a transplant rejection or a cancer patient,
such variability would not be acceptable.
19. SWITCHING
• In this context, the term ‘switching’ means that patients can be treated with the same type
of biopharmaceutical produced by different manufacturers during their treatment period.
• It is important to emphasise that it is not just a question of originator vs biosimilar switches,
but also switches between biosimilars.
• As these biologics and biosimilars are not identical, it is intensely discussed whether
these switches between biological products may increase the risk of immunogenic adverse
effects or loss of efficacy.
20. INTERCHANGEABILITY AND
SUBSTITUTION
• Interchangeability or substitution means dispensing of generic drugs in place of prescribed
innovator products.
• The rationale behind substitution of chemical drugs is that the original drugs and their
generics are identical and have the same therapeutic effect. For majority of chemical
generics, automatic substitution is appropriate and can produce cost savings.
• However, the same substitution rules should not be applied to biosimilars, as it may
decrease the safety of therapy or cause therapeutic failure.
21. NAMING AND LABELLING
• The international non-proprietary (INN) system of naming was established by the World
Health Organization in 1953 to promote “clear identification, safe prescription and
dispensing of medicines to patients, and for communication and exchange of information
among health professionals and scientists worldwide.”
• Non-proprietary name is given according to their API which is acceptable in case of
chemical medicine because generics are same copies of innovator but in case of
biosimilars it's not acceptable .
• biosimilars require unique INNs, as this would facilitate prescribing and dispensing of
biopharmaceuticals and also aid in precise pharmacovigilance.
• However biosimilars share non-proprietary names with the respective innovator products.
22. • For example, Remicade, which is the reference product for Inflectra as well as Remsima,
share the same international non-proprietary name infliximab.
• There should be comprehensive labelling of biosimilars including the deviations from
innovator product and unique safety and efficacy data, which would assist the physician
and pharmacist in making informed decisions.
23. ROLE OF PHARMACOVIGILANCE
• Pharmacovigilance (PV or PhV), is the pharmacological science relating to the collection,
detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical
products.
• Post-authorization pharmacovigilance is considered essential to guarantee the product’s safety
and efficacy over time; as part of a comprehensive risk management program, this includes
regular testing for consistent manufacturing of the drug.
• Pharmacovigilance is important in the biosimilars market because of the limited ability to predict
clinical consequences of seemingly innocuous changes in the manufacturing process and the
scientific information gap.
• Immunogenicity is a unique safety issue with biosimilars. However, lack of validation and
standardization of methods for detection of immunogenicity further implies the necessity for
robust pharmacovigilance.
24. • The adverse drugs reactions monitoring data should be exhaustive, including the type of
adverse event and data about drug such as proprietary name, international non-proprietary
name (INN) and dosage given.
• Pharmacovigilance systems should differentiate between licensed reference product and
biosimilar products so that effects of biosimilars are not lost in the background of reports on
licensed reference products.
• One of the greatest concerns about biological drugs is the risks associated with these
products over time because of the structural changes in the molecule, as these are derived
from microorganism. It is highly possible that the risk–benefit profile established at the time
of approval will change over time through expanded use, patient characteristics, and
patient exposure.
• Therefore, pharmacovigilance should be continued for biosimilars as long as the product is
in the market.
25. BENEFITS OF BIOSIMILARS
• biosimilars can be used in a large variety of diseases, such as cancer, cardiovascular
illnesses, haemophilia, autoimmune diseases such as multiple sclerosis
and rheumatoid arthritis, and rare genetic conditions such as Gaucher’s disease and Fabry
disease .
• Biosimilars are less costly than originator biologic agents primarily because biosimilars do
not have to undergo the intensive clinical development process associated with approval of
an originator.
26. • Due to its cost being lower than the original biological, biosimilars are more accessible to a
wider group of people and countries.
• It can allow high-quality health care to extend to developing countries and sensitive
populations.
• Approval of biosimilars create additional treatment options for often expensive brand-
name products. These options are good for patients, as there may be manufacturing
problems with a given biologic, in which case, having an approved biosimilar option can
help patients continue treatment.
27. REFERENCES
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biosimilars. Vol. 46, Journal of Industrial Microbiology and Biotechnology. Springer Verlag;
2019. p. 1297–311.
4. Misra M. Biosimilars: Current perspectives and future implications. Indian J Pharmacology.
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1;2(Supplement 1):i27–36
6. Ebbers HC, Schellekens H. Are we ready to close the discussion on the interchangeability of
biosimilars? Vol. 24, Drug Discovery Today. Elsevier Ltd; 2019. p. 1963–7.
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and risks [Internet]. Vol. 144, Swiss Medical Weekly. EMH Swiss Medical Publishers Ltd.; 2014.
8. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Vol. 19, Annals of Oncology.
2008. p. 411–9.
9. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: Considerations for U.S.
oncologists in clinical practice. Vol. 3, Cancer Medicine. Blackwell Publishing Ltd; 2014. p. 889–99
10.Oza B, Radhakrishna S, Pipalava P, Jose V. Pharmacovigilance of biosimilars-Why is it different
from generics and innovator biologics?. Vol. 65, Journal of Postgraduate Medicine. Wolters Kluwer
Medknow Publications; 2019. p. 227–32.