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Introduction to Biosimilars

Introduction to Biosimilars. Presented by:Dr / Kholoud Mamdouh. Biologicals Marketing Authorization Directorate Central Administration for Pharmaceutical Affairs www.eda.mohealth.gov.eg biologicals@eda.mohealth.gov.eg. Biosimilar concept (Q,S and E pov ). Biosimilars are not generics.

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Introduction to Biosimilars

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  1. Introduction to Biosimilars Presented by:Dr/KholoudMamdouh Biologicals Marketing Authorization Directorate Central Administration for Pharmaceutical Affairs www.eda.mohealth.gov.egbiologicals@eda.mohealth.gov.eg

  2. Biosimilar concept (Q,S and E pov) Biosimilars are not generics WHY

  3. EMA concept

  4. EMA concept

  5. Similar Versions Generic Vs Biosimilar

  6. Generic Vs Biosimilar

  7. Chemical Vs Biological Source: New England Journal of Medicines, “Developing the Nation’s Biosimilars Program,” August 4, 2011 Aspirin Vs Monoclonal antibody

  8. Chemical Vs Biological

  9. Product is the process

  10. Guidelines for changing the process

  11. Comparability of biotechnological/biological products subject to changes in their manufacturing process

  12. Comparability of biotechnological/biological products subject to changes in their manufacturing process

  13. Guidance for Industry Comparability Protocols Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information

  14. Problems issued from changing process of Epotinalfa • Diagnosis EPO antibody mediated PRCA cases • Unexplained loss of effect (LOE) • • Anaemia (Hb decreases by about 0.1 g/dl/day) • • Low reticulocyte count (< 10 000/μl) • • Platelets. White blood cells : normal • • Bone marrow (strongly recommended) • – Normal cellularity • – Erythroblasts very rare (< 5 %) • • Positive Epo antibody test

  15. Change in formulation Immune-response and adverse reactions: PRCA case example Nicole Casadevall - EMA

  16. Change in formulation continue The interaction of Tween and the uncoated rubber in pre-filled syringes appears to cause leachates. These leachates have been implicated in causing aggregation of epoetin molecules that then enhance their antigencity.

  17. Biosimilars guidance world wide

  18. Biosimilars guidance world wide

  19. EMA (Biosimilars) • First guide line 2005 • Scope: In principle, the concept of similar biological medicinal product is applicable to any biological product. However, in practice, the success of such a development approach will depend on the ability to characterise the product and therefore to demonstrate the similar nature of the concerned product • Reference • Should be licensed in EMA

  20. Approved EMA Biosimilar Products

  21. FDA (Biosimilars/Follow-on protein) FDC Act PHS Act ABBREVIATED APPROVAL PATHWAYS section 505 Section 351 pathway described in section 505(b)(2) (ANDA) process in section 505(j) Ammendment BPCI Act Generic drugs Follow on proteins Biosimilars

  22. Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing

  23. FDA (Follow on proteins) • Feb 2005 • Dec 2005 Sept 2004

  24. FDA (Follow on proteins) The Agency indicated its intention to issue guidance documents to specifically address human growth hormone and insulin. But, as our knowledge of this issue expanded, we reconsidered our focus and determined it would be more appropriate to initially promulgate guidance that is more broadly applicable to follow-on protein products in general. We are in the processof developing such guidance with respect to products approved under the FDC Act (updated 7/2009)

  25. FDA (Follow on protein) Approved follow-on proteins in FDA • Hylenex (hyaluronidase recombinant human) • Hydase(hyaluronidase) • Fortical(calcitonin salmon recombinant) Nasal Spray • Amphadase(hyaluronidase) • GlucaGen(glucagon recombinant for injection) • Omnitrope (somatropin [rDNA origin])

  26. Case Study: Omnitrope Omnitrope is the first recombinant human growth hormone product approved through the abbreviated pathway, Specifically, the approval was based on the following:

  27. FDA (Biosimilars) • Scope: • The guidance focuses on therapeutic protein products • Protein means any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. • Reference: • Should be licensed in US

  28. WHO (Similar Biotherapeutic Products SBPs) • Scope: • Applies to well-established and well-characterized biotherapeutic products such as recombinant DNA-derived therapeutic proteins. • Vaccines, plasma derived products, and their recombinant analogues are excluded from the scope • Reference:

  29. Health Canada (Subsequent Entry Biologic SEBs) • Scope: • The guidance applies to biologic drugs that contain, as their active substances, well characterized proteins derived through modern biotechnological methods such as use of recombinant DNA and/or cell culture • Canadian Guidelines shares the similar concept of the WHO

  30. Korean FDA (Biosimilars) CDSCO (Indian) (Similar Biologic) • Scope: • , well characterized proteins derived through modern biotechnological methods such as use of recombinant DNA technology • Rerefence: • Registrered in Scope: Similar to EMA Concept Reference: should be a biological product authorized in Korea. Preclinical and Clinical aspects Similar to WHO

  31. Thank You

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