FDA OKs First Biosimilar

The US Food and Drug Administration approves Sandoz’s Zarxio, a biosimilar to Amgen’s filgrastim, which is mainly prescribed for cancer patients.

Mar 6, 2015
Tracy Vence

Structure of filgrastimWIKIMEDIA, EUROPEAN BIOINFORMATICS INSTITUTEIn an agency first, the US Food and Drug Administration (FDA) today (March 6) announced its approval of a biosimilar drug. The FDA has green lighted Zarxio, a biosimilar produced by Novartis subsidiary Sandoz that is similar to Amgen’s Neupogen (filgrastim). Like filgrastim, Zarxio is intended for use by patients undergoing chemotherapy, as well as patients with severe chronic neutropenia—low neutrophil count—among other conditions.

In its announcement, the FDA noted that “a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product.” To be approved, the agency continued, a biosimilar “must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.”

Because the FDA has not yet decided on a naming policy for biosimilars, the agency has dubbed the newly approved product “filgrastim-sndz.”

“Biosimilars are likely to create greater competition in the medical marketplace,” Leah Christl, FDA’s associate director for therapeutic biologics, said in a statement.

“Biosimilars have the potential to increase access, and the approval of Zarxio may reduce costs to the healthcare system,” Louis Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University, said in a Novartis press release.