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news.The US Food and Drug Administration has accepted for filing Canadian pharmaceutical firm Apotex's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta.
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Apotex has been jointly developing the product in collaboration with Intas Pharmaceuticals.
The company’s application was filed under the 351(k) abbreviated approval pathway created by the q2Biosimilar Price Competition and Innovation Act (BPCIA).
Neulasta is the long acting formulation of Neupogen (filgrastim), which is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts.
Apotex president and chief executive officer Dr Jeremy Desai said: "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."
ApoBiologix, a division of Apotex, will be responsible for marketing the product in the US.