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A QUM partnership approach to regulating biosimilars in Australia

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Presentation on theme: "A QUM partnership approach to regulating biosimilars in Australia"— Presentation transcript:

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

5

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.


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