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Biosimilars & EU regulation

Biosimilars & EU regulation. Alice DOMINIQUE - M2 AREIPS. Content. Definitions. What is a biological medicine ?. Biological medicine = Biologic medical product = Biological = Biologic

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Biosimilars & EU regulation

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  1. Biosimilars& EU regulation Alice DOMINIQUE - M2 AREIPS

  2. Content

  3. Definitions

  4. Whatis a biologicalmedicine ? • Biological medicine = Biologic medical product = Biological = Biologic • Medicine made by or derived from a biological source (human, animal or microorganism), using biotechnology • Active substance larger and more complex than chemical medicine  Degree of variability • Examples : d

  5. Whatis a biosimilar ? • Similar biological = biosimilar medicine • A biological medicine developed to be similar to an existing biological medicine that has already been authorized for use. (‘Reference medicine’) • Active substance: essentially the same • Butminor differences due to their complex nature and production methods  Degree of naturalvariability • When approved, its variability and any differences between it and its reference medicine will have been shown not to affect safety or effectiveness

  6. Biosimilars ≠ Generics

  7. EU Regulation

  8. Regulation in EU • EU = first region to have set up a legal framework • Concept of biosimilaradopted in EU legislation in 2004 • Directive 2001/83/EC, as amended by Directive 2003/63/EG and Directive 2004/27/EC • First biosimilar medicine : approved by the EC in 2006 • Marketing authorisation application: Centralised Procedure • Only authorized once the period of data exclusivityhas expired

  9. EMA guidelines relevant for biosimilars • OVERARCHING BIOSIMILAR MEDICINES GUIDELINES • General • Quality • Non­clinical and Clinical • PRODUCT-SPECIFIC BIOSIMILAR MEDICINES GUIDELINES • Recombinant human insulin and insulin analogues • Somatropin • G­CSF • Recombinant erythropoietins • Low-molecular-weight heparins • Interferon IFN­β • FSH • Monoclonal antibodies

  10. Biosimilars authorised in EU

  11. How to demonstrate biosimilarity? • Similarity to the reference medicinal product in terms of:  based on a comprehensive comparability • Similar active substance, in molecular and biological terms • For example: for a protein, same amino acid sequence • Same posology and route of administration • Deviations from the reference product as regards strength, pharmaceutical form, formulation, excipients or presentation require justifications • Any difference should not compromise safety • Intended changes to improve efficacy are not compatible with the biosimilarity approach.

  12. Marketing Autorisation application dossier

  13. Biosimilars in practice

  14. Why do we use biosimilars? • In EU, in 2014 : 7/10 of the most sold medicines • Biological costs > Chemical medicines costs • Biosimilars: • More cost-effective alternative • Offer a major opportunity to provide greater access to affordable healthcare • Difficult production methods • Supply difficulties • Stock-outs

  15. Interchangeability • Medical practice of changing one medicine for another that is equivalent, in a given clinical setting on the initiative, or with the agreement of the prescriber • EMA: • Decisions on interchangeability : • Outside its remit • No recommendations • Rely on national competent authority • For questions related to switching from one biological medicine to another, patients should speak to their doctor or pharmacist

  16. Interchangeability • ANSM: • According to the evolution of the knowledge and the continuous analysis of efficiency and safety data of biosimilars in EU, it appears that a position excluding formally any interchangeability during the treatment is no longer justified • But, for security and traceability reasons it’s not recommended to modify the initial prescription FIMEA: “Biosimilars are interchangeable with their reference products under the supervision of a health care person”

  17. Conclusion

  18. Conclusion • Important sub-category of biologics • One the fastest growing segments of pharmaceutical industry • 2014: worldwide sales ≈ US$200 billion • Importance in healthcare budget • Complex structure • Small differences can result in a significant impact on quality, safety & efficacy • Importance of legislation and harmonisation

  19. Bibliography • http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000529.jsp&mid=WC0b01ac0580533e0b • Guideline on similar biological medicinal productsCHMP/437/04 Rev 1, 2014 • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMEA/CHMP/BMWP/42832/2005 Rev1, 2014 • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), EMA/CHMP/BWP/247713/2012 , 2014 • Biosimilarmedicineshandbook, 3rd edition - 2016, The BiosimilarMedicines Group • État des lieux sur les médicaments biosimilaires, Mai 2016, ANSM • http://www.amgenbiosimilars.com

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