Learning from our neighbors about regulation of biosimilar drugs

The recent enactment of the Biologics Price Competition and Innovation Act of 2009 has left several unanswered questions as to the U.S. regulatory future for follow-on versions of biologics, also known as “biosimilars.” The BPCIA establishes the framework for an abbreviated approval process for biosimilars, and the U.S. Food and Drug Administration is tasked with developing regulatory standards for approval. The European Union and other countries have already adopted approval guidelines for biosimilars, which may help the FDA and corporate counsel address the many challenges that the abbreviated approval of biosimilars presents.

The European Union has led the way in establishing a regulatory framework for the approval of biosimilars. Under the E.U. regulatory framework, the European Medicines Agency can approve “similar biological medicinal products.” See Committee for Medicinal Products for Human Use, Guideline on Similar Biological Medicinal Products, CHMP/437/04 (Oct. 30, 2005) (E.U. Guidelines). The guidelines interpreting the E.U. regulatory framework explain that “similar biological medicinal products” are distinct from “generic medicinal products” because of the subtle differences inherent in biological medicinal products synthesized by different manufacturers or when compared against reference products. E.U. Guidelines, at § 2.1.