The Food and Drug Administration has accepted Sandoz's Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.


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Sandoz files for FDA approval via new biosimilar pathway

July 24th, 2014

HOLZKIRCHEN, Germany – The Food and Drug Administration has accepted Sandoz's Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.

Sandoz said Thursday that the reference product — Amgen’s Neupogen — is indicated for decreasing the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

The Novartis subsidiary noted that it's the first company to announce it has filed for approval of a biologic under the biosimilars pathway.

“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S., and we applaud FDA for its progress in making this a reality,” said Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz. “Biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics while reducing the financial burden on payers and the overall health care system.”

Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the United States.

Sandoz is a pioneer in biosimilars and the global market leader, with over 50% share of all biosimilars approved in the highly regulated markets of Canada, Europe, Japan and Australia. Sandoz currently markets three biosimilars outside the U.S.; each of them occupies the No. 1 biosimilar position in its respective category.

Among those hailing the action was Generic Pharmaceutical Association president and chief executive officer Ralph Neas.

“For the first time, the FDA has accepted a filing for an approval of a biosimilar drug, a major step toward access for Americans to safe, effective alternatives to costly brand biologic medicines,” he said. “Biosimilars have been successfully used in Europe and other markets for years.

“Filgrastim’s filing acceptance moves us closer to the day when U.S. patients that currently must rely on costly brand biologics for treatment will have more choices for the medicine that they need.”

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