1. Is Australia ready for ? Is Australia ready for biosimilar ? David Lim, Julie Hepworth, Lisa Nissen c113.lim@qut.edu.au 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?

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

5. CC-BY,ND: @Doug88888

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 c113.lim@qut.edu.au CC-BY,ND, NC Lif