This is another perspective on the EU's proposed guidelines governing biosimilar antibodies from the PharmaTech Talk blog.
As previsously posted here, the EU is expected to require clinical trials for biosimilar mAbs. The question is the extent of testing that will be required for mAbs versus other biosimilar proteins like EPO or HGH. A rituximab biosimilar is likely to be the first test case.
Posted by Bruce Lehr November 24th 2010.