Biosimilars: it is not as simple as cost alone

Biosimilars/Research | Posted 29/07/2009 post-comment0 Post your comment

Biosimilars or follow-on biologics (FOBs) 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, FOBs 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.

Simon D Roger and D Goldsmith of the Gosford Hospital in Gosford, Australia, tried to determine the balance between costs surrounding FOBs (including relatively extensive developmental programmes and subsequent price to the market) and the necessity to ensure efficacy and safety.


Their principal findings were that it is important that FOBs are sufficiently tested to ensure patient safety is not compromised. Conducting such a development programme followed by sound pharmacovigilance is very challenging and costly. They concluded that cost-savings associated with FOBs may be limited.

Source: J Clin Pharm Ther. 2008 Oct;33(5):459-64.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010