Elisabeth White - Baker & McKenzie - Spotlight on biosimilars

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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