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.
Biosimilars: it is not as simple as cost alone
Biosimilars/Research
|
Posted 29/07/2009
0
Post your comment
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.
News
FDA approves denosumab biosimilars Stoboclo and Osenvelt
EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
General
Chinese biosimilars go global: growth, partnerships, and challenges
Stelara biosimilars enter US market with 85% discount in 2025
What is the future for the US biosimilar interchangeability designation

Biosimilars/Research Posted 05/06/2025
Biosimilar clinical efficacy studies: are they still necessary?

Biosimilars/Research Posted 27/05/2025
The best selling biotechnology drugs of 2008: the next biosimilars targets

Post your comment