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:
Is Australia ready for ? Is Australia ready for biosimilar ? David Lim, Julie Hepworth, Lisa Nissen CC-BY,NC Sarah Macmillan
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
What is Biosimilar?
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
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