A QUM partnership approach to regulating biosimilars in Australia

Lim, David, Siegel, Evan, Sunderland, V Bruce, Chan, Vincent, & Nissen, Lisa (2014) A QUM partnership approach to regulating biosimilars in Australia. In Antonio, Gloria, Brown, Jared, Dartnell, Jonathan, Heaney, Aine, Hosking, Kerren, Huang, Nancy, et al. (Eds.) National Medicines Symposium 2014 : Medicines in Health - Shaping Our Future, NPS Medicinewise, Brisbane, Australia, p. 57.

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Abstract

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

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ID Code: 73814
Item Type: Conference Paper
Refereed: Yes
Keywords: Pharmaceutical regulation, Biosimilar, Biological products, Biological pharmaceuticals, Health services
Subjects: Australian and New Zealand Standard Research Classification > TECHNOLOGY (100000) > MEDICAL BIOTECHNOLOGY (100400)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PHARMACOLOGY AND PHARMACEUTICAL SCIENCES (111500)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700) > Health Care Administration (111709)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700) > Public Health and Health Services not elsewhere classified (111799)
Divisions: Current > Schools > School of Clinical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Copyright Owner: Copyright 2014 Please consult the authors
Deposited On: 13 Jul 2014 23:54
Last Modified: 07 Oct 2016 12:41

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