Thursday, December 1, 2011

EMA Updating Biosimilars Gudielines

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The European Medical Association is updating their guidelines they set in place for biosimilars in 2005.  The concept paper has been released for consultation and that period will conclude in February 2012.

According to PM Live, a few of the things to be addressed in guideline CHMP/437/04 are:

- Determining whether or not a definition for "biosimilar"is necessary
- Should select biological products follow the legal basis for generics?
- Additional sections that need refinement since the initial realease of the guideline

The revised copy of CHMP/437/04 should be in the first half of 2012.

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