FDA Accepts First Biosimilar Filing

Jul 24, 2014
By PharmTech Editors

Sandoz, a Novartis Group company, announced July 24 that FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway.

The reference product, Amgen's NEUPOGEN, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

"This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality," said Mark McCamish, MD, PhD, and head of global biopharmaceutical & oncology injectables development at Sandoz. "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."

Under the brand name ZARZIO, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. ZARZIO is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share, the company reports.

Source: Sandoz