market.usThe EMA has asked the industry to share their thoughts on its draft guidelines for developing and assessing biosimilars. The idea is to make it easier for patients in the EU to get access to biosimilars, while also keeping Europe a good choice for developers.
Tag Archive for: Market Authorisation
PharmaMar SAThe General Court of the EU orders the European Commission to pay the costs in the case of Aplidin® against the Spanish company PharmaMar SA, in which an EU marketing authorisation was not granted due to conflict-of-interests within the CHMP of the European Medicines Agency.