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Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Filgrastim (Grastofil™).

Company currently has 2 biosimilar applications (filgrastim [Neupogen®] and pegfilgrastim [Neulasta®]) under active review by FDA.

Toronto, ON—Apotex, Inc, a rising competitor in the global biosimilars market, announced today that, as of February 13, 2015, the US Food and Drug Administration has accepted for filing the company's application for filgrastim [Grastofil™], a biosimilar version of Amgen's Neupogen®. This product has been jointly developed with Intas Pharmaceuticals Ltd.

This is the second follow-on biologic FDA submission for Apotex via the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA). Apotex also has a 351(k) biosimilar application for the long-acting pegylated formulation of filgrastim currently under FDA review. Apotex is the only company to date to have 2 biosimilar filgrastim applications (pegfilgrastim and filgrastim) currently under active review by FDA. Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. According to Symphony Health Solutions, Neupogen® had approximately $1 billion in sales in calendar year 2014.

"We are very pleased to be at the forefront of companies who will introduce high-quality biosimilar products into the US marketplace," said Apotex President and Chief Executive Officer, Dr. Jeremy B. Desai. "Our entry into this new frontier of medicine in the United States is a watershed event in Apotex's 40-year history of providing quality, affordable medicines to patients in need around the globe," Desai said. "The benefits for patients, payers, and providers from biosimilars will be significant. We are dedicated to playing a leading role in the effort to increase the American public's access to more affordable versions of these life-saving therapies and generate substantial savings for the US health care system," Desai added.

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