Sandoz takes step toward first U.S. generic biosimilar with FDA filing

HOLZKIRCHEN, Germany — The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced.

If approved, this would be the first biosimilar generic in the United States since the passage of the Biologics Price Competition and Innovation Act, which cuts down the approval process for potential biosimilar generics.

The application is to create a generic version of the biosimilar drug filgrastim, which is used to treat neutropenia, a condition that typically accompanies cancer or bone marrow diseases that causes a low white blood cell count. Amgen currently sells filgrastim as Neupogen. 

“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S.,” Sandoz’s head of global biopharmaceutical and oncology injectable,  Mark McCamish, said . “As they’ve done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”

Sandoz currently sells its version of filgrastim as Zarzio in 40 other countries.