To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies (mAbs)? This question was verified in a paper by Dr Christian Schneider –member of the EMA’s Committee for Medicinal products for Human Use (CHMP), Chairman of EMA’s Biological Medicines Working Party (BMWP) and the Paul-Ehrlich-Institut in Langen, Germany– and Dr Ulrich Kalinke of the Paul-Ehrlich-Institut and Twincore Center for Experimental and Clinical Infection Research in Hannover, Germany, as published in Nature Biotechnology of September 2008.
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