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Published byDoreen Mills Modified over 6 years ago
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A QUM partnership approach to regulating biosimilars in Australia
David Lim, Evan Siegel, V Bruce Sunderland, Vincent Chan, Lisa Nissen (C)
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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
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What is Biosimilar?
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http://www. tevagenerics
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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
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© National Medicines Policy
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© azlijamil@gmail.com, 2006. Used with permission.
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