European generic drugmakers calls for legal framework for biosimilars and registration via centralized route

The European Medicines Agency yesterday hosted the third EMA-EGA (European Generic Medicines Association) Info Day. There has been growing interest in the European generic medicines industry’s use of the Centralised Procedure in order to obtain a Marketing Authorization that is valid in all the European Economic Area (EEA) markets.

In his opening presentation, Greg Perry, director general of the EGA, said the industry could benefit from an efficient implementation by the Agency of the 2004 European Union pharmaceutical legislation, which set out a legal framework for biosimilar and generic registrations via the centralized route.

Mr Perry added that the Agency, together with experts from National Competent Authorities, pioneered the scientific framework for biosimilar medicines and continues to lead worldwide in developing scientific guidelines, the next one being for biosimilar monoclonal antibodies.