Europe's copy drugmakers set out vision for more efficient regulation of generics and biosimilars

The European Generic medicines Association (EGA) has published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, last week. The EGA believes that the regulatory environment needs to be optimised in order to fully exploit the advantages offered by generic and biosimilar medicines for the sake of health care sustainability.

The EGA Vision 2015 puts forward a series of proposals to improve the existing legal and regulatory framework aimed at guaranteeing timely patient access to affordable treatments by:

• enhancing the competitiveness of the generic and biosimilar medicines industry by creating a level playing field for global competition, harmonizing “GxP” practices and introducing a broader interpretation of the EU reference product;