This post from The BioProcess Blog gives a good overview of the recent EMA DRAFT guidelines for biosimilars - the same project FDA is currently trying to tackle in the US. The Bioprocess blog makes it clear that they think the EMA has taken a practical approach.
The EMA guidance makes it clear that the focus in clinical trials for biosimilar MAbs should be the demonstration of similar efficacy and safety between the biosimilar product and the reference product, not patient benefit per se, and recommends that the most sensitive patient population and clinical endpoint should be used to better identify potential product-related differences.
What's more? The ability to extrapolate “clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the biosimilar's clinical development will certainly accelerate development and reduce the overall costs of bringing these products to market.
The authors note that Europe continues to take the lead in establishing clear regulatory guidelines and requirements for biosimilars and is working diligently to allow European patients access to all types of biosimilar products. Canada will probably continue to follow the EMA’s lead so we expect a similar guidance from Health Canada soon.
Posted by Bruce Lehr Feb 1st 2011.