is australia ready for ? is australia ready for biosimilar ? david lim, julie hepworth, lisa nissen...
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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 < 生物等效物 >• Follow-on biopharmaceuticals < 生物等效品 >• Follow-on protein product• Subsequently entered biologic• Similar biologic medicinal product• Generic biological drug• Biogeneric• …
BIOSIMILAR < 生物相似性药品 >
CC-BY,NC Damian Navas
http://www.stellarix.com/blog/review-on-the-current-and-future-trends-of-biosimilar-market-in-usa-and-india/
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 < 中华人民共和国专利法 >• Consolidation of pharmaceutical distribution• Willingness of Chinese physicians to prescribe
biosimilar• Global pharmaceutical R&D hotspot
David Lim [email protected],ND, NC Lif