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Understanding Biosimilars: Regulations, Definitions, and Applications in the EU

Explore the concept of biosimilars, their regulations in the EU, the distinction from generics, authorization processes, and practical applications in healthcare. Learn about interchangeability and the importance of biosimilar legislation in the pharmaceutical industry.

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Understanding Biosimilars: Regulations, Definitions, and Applications in the EU

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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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