Is Australia ready for

biosimilar ?

David Lim, Julie Hepworth, Lisa Nissen

c113.lim@qut.edu.au

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

What is

Biosimilar?< 生物相似性药品 >

http://www.stellarix.com/blog/review-on-the-current-and-future-trends-of-biosimilar-market-in-usa-and-india/

CC-BY,ND: @Doug88888

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

Microsoft clipart

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

© National Medicines Policy

David Lim c113.lim@qut.edu.auCC-BY,ND, NC Lif