EMA Publishes “Biosimilar Friendly” Guidelines 
Posted by Carlos on Nov 29, 2010

On Friday, the EMA published draft guidelines on biosimilar medicines containing monoclonal antibodies. The guidelines are on the EMA site here, with a good overview available here.

The overview points out that not only is the original cell line not required, but you do not need to use the same cell system. While this may simplify the manufacturing process for some companies, it will also increase the data requirements for those biosimilar manufacturers who must deviate significantly from the original cell line.

This and other issues again suggests that the development of biosimilars will be an expensive proposition. Some analysts suggest that $100 million per-product per-indication is not unreasonable. This, in turn, may limit competition to those large companies who have the resources to invest these sizeable sums.

The end result? In the near-term, we probably will not see dramatic reductions in prices relative to branded biologics. Further, branded biologics will survive and possibly thrive through label expansion in this environment.

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