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BiosimilarSiriwan ChaisomboonpanBureau of Drug and Narcotic25 December 2008                              1
Outlines   What is a biological medicine?   What is a biopharmaceutical medicine?   What is a biosimilar medicine?   W...
What is a biological medicine ?   Is a medicine whose active substance is    made by or derived from a living    organism...
What is a biopharmaceutical medicine?    Biopharmaceutical     - A drug created by means of     biotechnology, especially...
How biopharmaceuticals made?1.   Develop host cell2.   Establish a cell bank3.   Protein production4.   Purification5.   A...
Develop host cell   Identify the human DNA sequence for the    desired protein   Isolate the DNA sequence   Select a ve...
Establish a cell bank   A cell bank is then established, using an    iterative and elaborate cell screening and    select...
Protein production   The conditions under which cells are    cultured can affect the nature of the    end product.       ...
Purification   Any change in the purification    process can affect the clinical    characteristics of the product       ...
Analysis   Protein molecules are analyzed for    uniformity in terms of structure and    potency.   A wide variety of an...
Analysis (cont.)   These tests remain limited in their    ability to detect all product    characteristics that may affec...
Formulation   Formulation is a key step in stabilizing    the protein.   The components of the formulation,    and the p...
Storage and handling   Biopharmaceuticals are very sensitive to    temperature changes and/or shaking.   Strict storage ...
Manufacturing low molecularweight drugs Low molecular weight drugs are made by adding and mixing together known chemicals ...
Differences in manufacturing   The manufacturing process for a    biopharmaceutical is far more complex    than that for ...
Quality of products   Each of these stages can have a    major influence on the characteristics    of the biopharmaceutic...
What is a biosimilar medicine?   Is a medicine which similar to biological     biopharmaceutical medicine that has    alr...
What is a biosimilar medicine? (cont.)   Similar biotechnology medicinal products    = a new type of generic    biopharma...
What is the importance ofbiosimilar?   Biopharmaceuticals represent one    of the fastest-growing segments of    pharmace...
Other related terms   Biogeneric   Follow-On Protein   Follow-On Biologic                         20
Basic to view and define biosimilar   Entity-Based (including Product = Process)   Regulatory-Based (under an abbreviate...
Entity-Based   Based on consideration of their       Chemical and/or biological source       Identity (structure)     ...
Example: Process = Product   Cheddar cheese and red wine from    different manufactures are unique (e.g. in    flavor or ...
Related Guidelines   European Medicines Agency Evaluation    of Medicines for Human Use                                  ...
EMEA Guidelines   Similar biological medicinal products, Oct 2005   Similar biological medicinal products containing    ...
EMEA Guidelines (cont.)   Similar biological medicinal products containing biotechnology-    derived proteins as active s...
Non-Clinical and Clinical Issues,Feb 2006 (cont.)     Clinical safety and pharmacovigilance      requirement     Immunog...
Annex : Non-Clinical and ClinicalIssues   Recombinant Erythropoietin   Recombinant Human Soluble Insulin   Recombinant ...
Conclusions   The manufacturing process for    biopharmaceuticals (and biosimilars) is far more    complex than for low m...
Points to consider   Can a new manufacturer produce a biosimilar    that is similar enough to the original    biopharmace...
References   Basant Sharma, PhD :Manufacturing differences between    biopharmaceuticals and low molecular weight drugs 2...
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Biosimilar

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Biosimilar

  1. 1. BiosimilarSiriwan ChaisomboonpanBureau of Drug and Narcotic25 December 2008 1
  2. 2. Outlines What is a biological medicine? What is a biopharmaceutical medicine? What is a biosimilar medicine? What is the importance of biosimilar? Which are the related guidelines? 2
  3. 3. What is a biological medicine ? Is a medicine whose active substance is made by or derived from a living organism. Example such as : insulin can be produced by a living organism. 3
  4. 4. What is a biopharmaceutical medicine?  Biopharmaceutical - A drug created by means of biotechnology, especially genetic engineering. - A pharmaceutical inherently biological in nature and manufactured using biotechnology. 4
  5. 5. How biopharmaceuticals made?1. Develop host cell2. Establish a cell bank3. Protein production4. Purification5. Analysis6. Formulation7. Storage and handling 5
  6. 6. Develop host cell Identify the human DNA sequence for the desired protein Isolate the DNA sequence Select a vector to carry the gene Insert the gene into the genome of a host (a suitable bacterial or eukaryotic cell) The exact DNA sequence and the type of host cell used will significantly influence the characteristics of the product 6
  7. 7. Establish a cell bank A cell bank is then established, using an iterative and elaborate cell screening and selection process, yielding a unique master cell bank. No two master cell banks are exactly alike. 7
  8. 8. Protein production The conditions under which cells are cultured can affect the nature of the end product. 8
  9. 9. Purification Any change in the purification process can affect the clinical characteristics of the product 9
  10. 10. Analysis Protein molecules are analyzed for uniformity in terms of structure and potency. A wide variety of analytical tools is used to examine: 3D structure/Aggregation/ Isoform profile, including glycosylation patterns/ Heterogeneity/Potency 10
  11. 11. Analysis (cont.) These tests remain limited in their ability to detect all product characteristics that may affect clinical efficacy and safety. 11
  12. 12. Formulation Formulation is a key step in stabilizing the protein. The components of the formulation, and the process used, can significantly affect the product’s behavior in patients. 12
  13. 13. Storage and handling Biopharmaceuticals are very sensitive to temperature changes and/or shaking. Strict storage and handling conditions are therefore essential for maintaining product integrity and stability. Poor adherence to (cold) storage requirements can affect clinical efficacy and safety. 13
  14. 14. Manufacturing low molecularweight drugs Low molecular weight drugs are made by adding and mixing together known chemicals and reagents, in a series of controlled and predictable chemical reactions. This is organic chemistry 14
  15. 15. Differences in manufacturing The manufacturing process for a biopharmaceutical is far more complex than that for a low molecular weight drug. For biopharmaceuticals, much more than for low molecular weight drugs, the quality of the end product (including therapeutic efficacy and safety) is depended on the manufacturing process. 15
  16. 16. Quality of products Each of these stages can have a major influence on the characteristics of the biopharmaceutical end product. These differences clearly apply to biosimilars as well as to original biopharmaceuticals. 16
  17. 17. What is a biosimilar medicine? Is a medicine which similar to biological biopharmaceutical medicine that has already been authorized (the biological/ biopharmaceutical reference medicine). The active substance of a biosimilar is similar to the one of biological/ biopharmaceutical reference medicine. Used in the same dose to treat the same disease. 17
  18. 18. What is a biosimilar medicine? (cont.) Similar biotechnology medicinal products = a new type of generic biopharmaceutical approval in the EU. It is similar but not identical. 18
  19. 19. What is the importance ofbiosimilar? Biopharmaceuticals represent one of the fastest-growing segments of pharmaceutical industry. By 2010 they are expected to represent 50% of the market. Patent of original product expired. Increase opportunity to healthcare services, decrease expenditures. 19
  20. 20. Other related terms Biogeneric Follow-On Protein Follow-On Biologic 20
  21. 21. Basic to view and define biosimilar Entity-Based (including Product = Process) Regulatory-Based (under an abbreviated testing and/or filing scheme) Market-Based (same manufacturers, different trade name) 21
  22. 22. Entity-Based Based on consideration of their  Chemical and/or biological source  Identity (structure)  Activities  Manufacturing process  Specification  Predictions of product safety and efficacy based on knowledge of one or more similar products. 22
  23. 23. Example: Process = Product Cheddar cheese and red wine from different manufactures are unique (e.g. in flavor or texture). But they may be treated as the same (generic equivalent) and be assigned the same generic product name. 23
  24. 24. Related Guidelines European Medicines Agency Evaluation of Medicines for Human Use 24
  25. 25. EMEA Guidelines Similar biological medicinal products, Oct 2005 Similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality Issues, Feb 2006  Manufacturing process, comparability to reference  Suitability of analytical method, physicochemical properties, biological activity, purity and impurities, specification 25
  26. 26. EMEA Guidelines (cont.) Similar biological medicinal products containing biotechnology- derived proteins as active substance: Non-Clinical and Clinical Issues, Feb 2006  Non clinical data : in vitro, in vivo studies (Pharmacodynamic effect, toxicity)  Clinical studies :Pharmacokinetic, Pharmacodynamic, Efficacy trials 26
  27. 27. Non-Clinical and Clinical Issues,Feb 2006 (cont.)  Clinical safety and pharmacovigilance requirement  Immunogenicity  Factor affecting immunogenicity  Consequences of an immune response  Principle for evaluation of immunogenicity  Testing  Evaluation of the clinical significance of the observed immune response 27
  28. 28. Annex : Non-Clinical and ClinicalIssues Recombinant Erythropoietin Recombinant Human Soluble Insulin Recombinant Granulocyte-Colony Stimulating Factor Somatropin 28
  29. 29. Conclusions The manufacturing process for biopharmaceuticals (and biosimilars) is far more complex than for low molecular weight drugs (and generics). Any (minor) change made at any stage may have a critical effect on the clinical efficacy and safety. Major manufacturing changes include:  producing a biosimilar  opening/starting a new production site  scaling-up to meet market demands The process is the product’ 29
  30. 30. Points to consider Can a new manufacturer produce a biosimilar that is similar enough to the original biopharmaceutical to be considered the same? How can the level of similarity be established without access to the bulk material? Are there risks associated with currently undetectable differences? How similar is similar enough? 30
  31. 31. References Basant Sharma, PhD :Manufacturing differences between biopharmaceuticals and low molecular weight drugs 2005. EMEA :Guideline on Similar Biological Medicinal Product 2005-2006 EMEA :Question and Answers on biosimilar medicines 2006 WWW.nature.com/naturebiotechnology 31

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