Court ruling sets stage for Sandoz to launch first U.S. biosimilar

Sandoz’s Zarxio is a biosimilar version of Amgen’s Neupogen.

HOLZKIRCHEN, Germany — Novartis will be able to introduce Sandoz’s Zarxio (filgrastim) after Sept. 2, the U.S. Court of Appeal for the Federal Circuit ruled Wednesday. Once launched, Zarxio will be the first biosimilar drug in the U.S.

Part of the court’s decision said that a company whose biosimilar has been approved by the Food and Drug Administration must give notice of commercial marketing to the original drug maker 180 days before the intended launch. In the case of Zarxio, which the FDA approved March 6, the ruling allows for a launch anytime after Sept. 2.

“We welcome the Federal Circuit’s finding,” Sandoz’s Global Head of biopharmaceuticals and injectables Carol Lynch said.

Though Sandoz markets Zarxio as Zarzio in 60 countries, this will be the first biosimilar drug available in the U.S. following the passage of the Biologics Price Competition and Fairness Act in 2009.

“We look forward to launching Zarxio after September 2 as the first US biosimilar,” Lynch said.