1. A QUM partnership approach to regulating biosimilars in Australia
David Lim, Evan Siegel, V Bruce Sunderland, Vincent Chan, Lisa Nissen
(C)

2. Biosimilars Biotech proteins Biotech drugs Biopharmaceuticals
Follow-on biologic products
Follow-on biopharmaceuticals
Follow-on protein products
Subsequently entered biologics
Similar biologic medicinal products
Generic biological drugs
Biogenerics …
Biosimilars

3. What is Biosimilar?

4. http://www. tevagenerics

6. Issues with biosimilar regulation
Economic potential
Patent protection
Reward innovation
Globalisation and international regulation
Quality, safety and efficacy
National Health Act 1953 (Cth)
Interchangeability and substitution
Prescriber aware

7. © National Medicines Policy

8. © azlijamil@gmail.com, 2006. Used with permission.