Please use this identifier to cite or link to this item: https://hdl.handle.net/1/242
Title: Biosimilars: It's not as simple as cost alone
Authors: Roger, Simon D ;Goldsmith, David J A 
Issue Date: Oct-2008
Source: Volume 33, Issue 5, pp. 459-464
Journal title: Journal of Clinical Pharmacy & Therapeutics
Abstract: BACKGROUND: Biosimilars or follow-on biologics (FoB) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FoB require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FoB marketing approval are not feasible. OBJECTIVE: To determine the balance between costs surrounding FoB (including relatively extensive developmental programmes and subsequent price to the market) and the necessity to ensure efficacy and safety. PRINCIPAL FINDINGS: It is important that FoB are sufficiently tested to ensure patient safety is not compromised. Conducting such a development programme followed by sound pharmacovigilance is very challenging and costly. CONCLUSIONS: Cost-savings associated with FoB may be limited.
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/242
DOI: 10.1111/j.1365-2710.2008.00942.x.
Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/18834359
ISSN: 1365-2710
Publicaton type: Journal Article
Keywords: Biosimilars
Appears in Collections:Renal Medicine

Show full item record

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.