According to Reuters interview with EMA executive director Thomas Lonngren, initial guidelines for biosimilar mAbs will be issued in November. Guidelines will be subject to 6 months review by the external commentators before they are formally adopted in the latter part of 2011.
Europe has approved 13 biosimilars to date but no monoclonal antibodies. These include biosimilare versions of HGH, EPO and G-CSF. So far, the EMA has had inquiries for scientific advice on 6 mAb biosimilar targets.
The EMA knows that it will require clinical trials for the mAbs to show they work similarly to the original licensed drug. EMA says these will be "less onerous than the US" as the agency will not give a view on subsitutability of the biosimilar. Teva, Novartis and Hospira are among the companies that are expected to be first in line with biosimilar mAbs. The EMA expects to see only 2-3 such applications per year given the greater complexity to produce these molecules.
Posted by Bruce Lehr October 4th 2010.