Biosimilars Regulations Being Developed in Both Europe and the United States

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November 4, 2010
News | Patents

The European Medicines Agency (EMA) issued draft guidelines for “similar biological medicinal products containing monoclonal antibodies” on November 26, 2010, requesting public comment by May 31, 2011.

The EMA has been ahead of the FDA on establishing regulations for biosimilars. Last month, the FDA held two days of hearings to get input from the public on the implementing regulations for the Biologics Price Competition and Innovation Act (BPCIA). These hearings related to establishing standards that the FDA will require for clinical testing of biosimilars.

Concerns highlighted at the FDA hearings included how strictly to interpret the 12 year data exclusivity provisions, product naming issues, and how to address product “drift” in post-market products, both for innovator products and their potential biosimilar competitors. The basic issues of what is biosimilar, and the related question of what is interchangeable, remain complex and will not be resolved soon.

Since it is believed that to some extent the United States’ biosimilars regulations may be influenced by what the EMA does, interested parties may wish to provide input to the EMA, as well as to the FDA, as these guidelines evolve into governing regulations.

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