How Are Biosimilars Regulated?

The European Medicines Agency (EMA) was the first body to develop an overarching framework for approving biosimilars. Biosimilars have been approved for use in the European Union since 2006; they also have been approved for use in Australia, Japan, and Latin America.

In the United States, a regulatory pathway for approval of biosimilars was made possible by the Biologics Price Competition and Innovation Act (BCPIA), a provision included in the Patient Protection and Affordable Care Act (Affordable Care Act) of 2010. The BCPIA created an abbreviated licensure (approval) pathway for biosimilar products that have the same mechanism of action, route of administration, dosage form, and strength as the original reference product. The biosimilar product may be approved only for the indications and conditions of use that have been approved for the reference product.

The FDA evaluates the safety and effectiveness of all new, original biologics, just as it does for new conventional medications. The goal of biosimilar development is to demonstrate that the proposed biosimilar is “highly similar” to the reference product, with comparable safety and effectiveness.