FDA Accepts Novartis Firm Sandoz's BLA For Filgrastim

Novartis’ generic pharmaceuticals division Sandoz announced that its Biologics License Application (BLA) for filgrastim has been accepted for review by the U.S. Food and Drug Administration (FDA).

Filgrastim is a biosimilar of Amgen’s Neupogen, indicated for the reduction of infection in patients with nonmyeloid malignancies taking myelosuppressive anticancer drugs related to a significant incidence of severe neutropenia with fever. The infection is most commonly manifested as febrile neutropenia in patients with low white blood cell counts.

Dr. Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development at Sando, said, “As they've done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”

The Neupogen biosimilar is marketed by Sandoz as Zarzio in over 40 countries outside the U.S. Novartis said Zarzio is currently the leading biosimilar of filgrastim worldwide and has a 30 percent volume market in Europe as a daily G-CSF. The company filed its BLA for filgrastim under the new pathway forged in the U.S. Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The FDA’s acceptance of Sandoz’s filing under BPCIA is a milestone in the distribution of cheaper copies of injectable biotech drugs in the U.S., reports Reuters. The fact that biotech drugs are produced from living cells makes it impossible to manufacture exact copies, and U.S. regulators have to adapt specific approval processes for biosimilars commercialization.

Earlier this month Sandoz’s branded dermatology business PharmaDerm announced an agreement with Anacor Pharmaceuticals to gain exclusive rights to the latter’s Kerydintm (tavaborole) topical solution in the U.S. Anacor secured FDA approval for the drug two weeks before the agreement.

Sandoz also announced that its Chief Scientific Officer Dr. Joerg Windisch, was reelected by the European Generic medicines Agency (EGA) as chair of its European Biosimilars Group (EBG).