From Dr. Stefan Danner
On November 18, 2010, the European Medicines Agency (EMA) released draft versions of two guidelines relating to the regulatory approval of monoclonal antibodies: the “Guideline on biological medicinal products containing monoclonal antibodies”1 and the “Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use”.2 Both guidelines are now subject to public consultation until May 31, 2011.
The former regulation for the approval of biosimilar monoclonal antibodies (mAb) was long-awaited by the pharmaceutical industry, as many basic patents for therapeutic mAb will expire within the next couple of years. The present guideline sets forth the non-clinical and clinical requirements for mAb-containing medicinal products claiming to be similar to another one already marketed (i.e., biosimilars) and complements several previous guidelines for biosimilar medicinal products, based on which 13 such products have been approved so far in Europe.
The second guideline on the immunogenicity assessment of mAb that was released by the EMA is applicable to all biological medicinal products containing mAbs, not just biosimilars.