Elisabeth White - Baker & McKenzie - Spotlight on biosimilars


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Elisabeth White delivered the presentation at 2014 Future of the PBS Summit.

The 11th annual Future of the PBS Summit marks a wonderful opportunity to review future frameworks and preferred outcomes for pharmacy regulators, pharmaceutical companies and wholesalers, practitioners, educators and consumers.

For more information about the event, please visit: http://www.informa.com.au/futurepbs14

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Elisabeth White - Baker & McKenzie - Spotlight on biosimilars

  1. 1. 11th Annual Future of the PBS Summit Spotlight on biosimilars Elisabeth White, Partner, Baker & McKenzie 5 May 2014
  2. 2. 2 Biologics & Biosimilars
  3. 3. Small Molecule Examples Paracetamol Codeine Aspirin 3
  4. 4. Large Molecule Examples Immunoglobulin G 4
  5. 5. Growth in the biologics market 5 –  IMS estimates that biologics will account for around 19% to 20% of the total pharmaceutical sales globally by 2017, with a projected market value of USD 221 billion –  Growth is driven largely by Monoclonal Antibodies (MAB) and human insulin –  The US still commands majority of biologic sales with a market share of 43%, followed by the EU (21%) and Japan (9%) Source: IMS Health Thought Leadership
  6. 6. Blockbuster Biologic Products 6 AbbVie
  7. 7. Monoclonal Antibodies 7 Monoclonal Antibodies are protein molecules produced by the immune system specifically targeted at certain substance E.g. Humira, Herceptin, Avastin, Enbrel
  8. 8. Importance of Biologics 8 Source: Capital IQ, AbbVie, Amgen and Roche 2012 Annual Reports
  9. 9. Forecast revenues of selected blockbusters post-patent 9
  10. 10. “Biosimilar”– similar but not the same – follow-on biologic / subsequent entry biologic / similar biological medicinal product – not bioequivalent or generic – manufactured differently through different bio-system, e.g. recombinant DNA, bacterial strain and purification – no products are exactly the same due to different amino acid sequence, impurities and 3D structure. – huge barrier of entry for new players due to complex manufacturing process 10
  11. 11. Biosimilar vs. Chemical Generic 11
  12. 12. Key issues 12 Prescribing practices Regulatory pathway Reimbursement
  13. 13. Australian biosimilars regime 13 Department of Health TGA •  Comparability / clinical data on safety and efficacy •  Abridged data set and regulatory pathway •  Naming •  Indications and extrapolation •  PV Pharmaceutical Benefits Division •  Safety •  Efficacy •  Interchangeability •  Substitutibility •  Pricing
  14. 14. Alliance for Safe Biologic Medicines Survey 2013 -  470 physicians in Europe -  54%: basic understanding of biosimilars -  22%: familiar with this category of medicine -  24%: cannot define or heard of biosimilars -  54%: thought same INN meant the products were structurally the same -  Most prefer to prescribe brand name products 14
  15. 15. Australian Approved Biosimilars Biologic Biosimilar Eprex® (epoetin alfa) Janssen Cilag Aczicrit® (epoetin lamda) Sandoz Grandicrit® (epoetin lambda) Sandoz Novicrit® (epoetin lambda) Novartis Neupogen® (filgrastim) Amgen Nivestim® (filgrastim) Hospira Tevagrastim® (filgrastim) Aspen Zarzio® (filgrastim) Sandoz Genotropin® (somatropin) Pfizer Omnitrope® (somatropin) Sandoz SciTropin® (somatropin) SciGen Australia 15
  16. 16. It’s all in the name… INN: International Non-Proprietary Name ABN: Australian Biologic Name ABN for biosimilars: reference product ABN + identifier sim(a) and WHO code eg infliximab simfam 16
  17. 17. Implications of TGA naming policy for PBS regime – pursuant to section 85AB National Health Act, the Minister: – determines whether a listed drug is on F1 or F2 – may only determine a drug is on F1 if the drug satisfies all the criteria for F1 – criteria for F1 set out in section 85AB(4) – biosimilar used in NH Act but undefined – the references to drug or listed drug (i.e. ABN) in section 85AB(4) become determinative 17
  18. 18. F1 criteria a)  there are no branded items of pharmaceutical products that: i.  have the drug; and ii.  are bioequivalent or biosimilar; and iii.  are listed brands of the pharmaceutical items on any day in the relevant period; b)  there are no brands of pharmaceutical items that: i.  have another listed drug that is in the same therapeutic group as the drug; and ii.  are bioequivalent or biosimilar; and iii.  are listed brands of the pharmaceutical items on any day in the relevant period; c)  the drug was not on F2 on the day before the formulary determination comes into force 18
  19. 19. Key issues and the way forward? 19 TGA naming policy determinative of formulary allocation? Substitutability / interchangeability ‘a’ flagging How do biosimilars fit within the philosophy of the formularies and pricing policy? F3?
  20. 20. 20 WATCH THIS SPACE!
  21. 21. Questions 21