A QUM partnership approach to regulating biosimilars in Australia


Autoria(s): Lim, David; Siegel, Evan; Sunderland, V Bruce; Chan, Vincent; Nissen, Lisa
Contribuinte(s)

Antonio, Gloria

Brown, Jared

Dartnell, Jonathan

Heaney, Aine

Hosking, Kerren

Huang, Nancy

Husband, Alan

Kay, Debra

Lindner, Robyn

Phillips, Stephen

Price, Kay

Reeve, James

Rigby, Debbie

Stowasser, Danielle

Turner, Peter

Walker, Christine

Walsh, Diane

Weekes, Lynn

Zuo, Yeqin

Data(s)

01/05/2014

Resumo

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.

Formato

application/pdf

application/vnd.openxmlformats-officedocument.presentationml.presentation

Identificador

http://eprints.qut.edu.au/73814/

Publicador

NPS Medicinewise

Relação

http://eprints.qut.edu.au/73814/3/73814.pdf

http://eprints.qut.edu.au/73814/2/Lim.pptx

http://www.nps.org.au/topics/nms

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.

Direitos

Copyright 2014 Please consult the authors

Fonte

School of Clinical Sciences; Faculty of Health

Palavras-Chave #100400 MEDICAL BIOTECHNOLOGY #111500 PHARMACOLOGY AND PHARMACEUTICAL SCIENCES #111709 Health Care Administration #111799 Public Health and Health Services not elsewhere classified #Pharmaceutical regulation #Biosimilar #Biological products #Biological pharmaceuticals #Health services
Tipo

Conference Paper