Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil™)

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

TORONTO, Feb. 17, 2015 /CNW/ - Apotex Inc., a rising competitor in the global biosimilars market, announced today that, as of February 13th, 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 351k biosimilar application for the long acting pegylated formulation of filgrastim currently under FDA review.  Apotex is the only company to date to have two 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 added. "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.

The product will be marketed in the United States by ApoBiologix®, a division of Apotex Corp.

About Apotex

Apotex is the largest Canadian owned pharmaceutical company with over 10,000 employees globally and with estimated sales of approximately $2 billion. The company's US headquarters is based in Weston, Florida. With its worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries. It has 500 products under development and will spend $2 billion over the next 10 years on research and development.

SOURCE Apotex Inc.

For further information: Mr. Elie Betito, Director of Public and Government Affairs, Apotex Inc., Tel: 416-749-9300 Ext. 7366, Cell: 416-558-5491, Email: ebetito@apotex.com


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