BioCentury
ARTICLE | Politics & Policy

EMA to accept ex-EU comparators for biosimilars

September 29, 2012 1:17 AM UTC

EMA is changing its biosimilar policies to make it easier for manufacturers to develop biosimilars in both the U.S. and Europe. In a statement released Friday, the agency said it is revising guidance to accept data showing comparability to ex-EU versions of reference products. EMA said the changes, which were first proposed in June by the European Commission, would avoid unnecessary repetition of clinical trials. A draft version of the new guidance is expected early next year. ...