The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.
It is largely up to the FDA. In the U.S., what constitutes “highly similar” in the context of biosimilars is ultimately up to how the U.S. Food and Drug Admininstration applies the statutory language under the Biologics Price Competition and Innovation Act of 2009 (PDF). Demonstration that a biological product is “highly similar” to its