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24 Dec 2014

Insight on usfda biosimilar application of pegfilgrastim

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the level of white blood cells (neutrophils).

Amgen manufactures pegfilgrastim under the brand name Neulasta, which was mainly worked on by Martine Allard, while Roche manufactures it under the name Neulastim.

In India it is also marketed by Abbott Healthcare under the brand name Imupeg. The drug is prepared by coupling a 20 kDa polyethylene glycol (PEG) molecule to the N-terminus of the filgrastim protein. Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).

Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that the US Food and Drug Administration has accepted for filing the company’s application for pegfilgrastim, a biosimilar version of Amgen’s Neulasta®. The product has been jointly developed with Intas Pharmaceuticals Ltd. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).

Neulasta® is the long acting formulation of Neupogen® (filgrastim). Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. Apotex believes it is the first company to have a biosimilar filing accepted for review by FDA for the long acting formulation of the product. According to IMS Health, Neulasta® had approximately $3.6 billion in sales in calendar year 2013.



We are very pleased to be at the forefront of companies who will introduce high quality biosimilar products into the US marketplace, 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, 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,

Dr. Jeremy B. Desai, Apotex President and Chief Executive Officer


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

Apotex is the largest Canadian owned pharmaceutical company with over 5,500 employees. Globally it has another approximately 4,500 employees 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.


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