Today the Patent Doc blog provides some nice coverage on the EMA published guidelines for biosimilar monoclonal antibodies. The guidelines will now be subjected to public comment until May 31, 2011. The FDA will undoubtedly be watching with interest as it is currently tasked to come up with similar guidelines for the US following the healthcare reform legislation this past Spring.
The first installment of the guidelines is entitled, "Guidelines on similar biological medicinal products containing monoclonal antibodies" and covers non-clinical and clinical studies.
The second set of guidelines addresses the problems with detection and risk related to the development of the mAb response - i.e. immunogenicity.
Posted by Bruce Lehr December 3rd 2011.