FDA Law Blog Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation

The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs.  In a joint letter to the European Commission’s Trade Commissioner and the US Trade Representative, GPhA and the European Generic medicines Association (“EGA”) made recommendations that “regulatory convergence” be included in the negotiations for the Transatlantic Trade and Investment Partnership (“TTIP”).  TTIP is a prospective trade agreement that is currently being negotiated between the European Union and the United States.  It is intended to remove trade barriers in a wide range of economic sectors to make it easier to buy and sell goods and services between the EU and the US.
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