FDA Approves First Biosimilar Drug

On Friday, March 6, the Food and Drug Administration approved the first biosimilar drug for use in the United States. Zarxio, produced by Sandoz and used to prevent infections in cancer patients who are receiving chemotherapy, is a close copy of Neupogen, a biologic drug produced by Amgen. Zarxio was approved under the Biologics Price Competition and Innovation Act of 2009, part of the 2010 Patient Protection and Affordable Care Act. This 2009 law created a pathway to market for biologic products demonstrated to be highly similar, or biosimilar, to an existing FDA-approved biologic drug.

Biologics are derived from living cells and produced through more complicated processes than those used for traditional brand-name and generic drugs. Biosimilars have the potential to produce cost savings and improve patient access to needed medications. Although they are not identical to biologics, there is no clinically meaningful difference between them. In a news release, FDA Commissioner Margaret A. Hamburg, M.D., said, “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy, and quality standards.”

Biosimilars have been available in Europe for the past decade, where their accessibility has led to lower prices for some biologics. Pew’s specialty drugs research initiative is exploring policies that could lead to similar savings in the United States.