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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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11th Annual Future of the PBS Summit Spotlight on biosimilars
Elisabeth White, Partner, Baker & McKenzie 5 May 2014
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Biologics & Biosimilars
Small Molecule Examples
Paracetamol
Codeine
Aspirin
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Large Molecule Examples
Immunoglobulin G 4
Growth in the biologics market
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– 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
Blockbuster Biologic Products
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AbbVie
Monoclonal Antibodies
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Monoclonal Antibodies are protein molecules produced by the immune system specifically targeted at certain substance E.g. Humira, Herceptin, Avastin, Enbrel
Importance of Biologics
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Source: Capital IQ, AbbVie, Amgen and Roche 2012 Annual Reports
Forecast revenues of selected blockbusters post-patent
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“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
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Biosimilar vs. Chemical Generic
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Key issues
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Prescribing practices
Regulatory pathway
Reimbursement
Australian biosimilars regime
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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
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
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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
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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
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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
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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
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Key issues and the way forward?
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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?
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WATCH THIS SPACE!
Questions
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