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Is Australia ready for ? Is Australia ready for biosimilar ? David Lim, Julie Hepworth, Lisa Nissen CC-BY,NC Sarah Macmillan.

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Presentation on theme: "Is Australia ready for ? Is Australia ready for biosimilar ? David Lim, Julie Hepworth, Lisa Nissen CC-BY,NC Sarah Macmillan."— Presentation transcript:

1 Is Australia ready for ? Is Australia ready for biosimilar ? David Lim, Julie Hepworth, Lisa Nissen CC-BY,NC Sarah Macmillan

2 Biotech protein Biotech drug Biopharmaceutical Follow-on biologic product Follow-on biopharmaceuticals Follow-on protein product Subsequently entered biologic Similar biologic medicinal product Generic biological drug Biogeneric … B IOSIMILAR CC-BY,NC Damian Navas

3 What is Biosimilar?

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6 Issues with Australia’s biosimilar regulation Economic potential – Patent to reward innovation – Registration – Raising the Bar (2013) Globalisation and international regulation Quality, safety and efficacy – Therapeutic Goods Act 1989 – National Health Act 1953 – Interchangeability and substitution – Prescriber and dispenser aware Equity of access

7 Microsoft clipart

8 China Increase healthcare expenditure Change from infectious disease to chronic disease Price discount from biosimilar Pre - Patent Law 1984 Consolidation of pharmaceutical distribution Willingness of Chinese physicians to prescribe biosimilar Global pharmaceutical R&D hotspot

9 © National Medicines Policy

10 David Lim CC-BY,ND, NC Lif


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