Sandoz resubmits Neulasta biosimilar application to FDA

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Sandoz resubmits Neulasta biosimilar application to FDA

By Sandra Levy - 04/12/2019
Novartis’ Sandoz division has resubmitted its Biologics License Application for a proposed biosimilar of pegfilgrastim to the Food and Drug Administration to address an FDA complete response letter received in June 2016.

Pegfilgrastim is a biosimilar of Amgen’s Neulasta (filgrastim). It is a long-acting version of filgrastim and may be prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells.

In the United States, 4,000 cancer patients die of febrile neutropenia and 60,000 are hospitalized due to neutropenia annually, the company said.

"For the tens of thousands of U.S. cancer patients undergoing chemotherapy, treatment options that can be individualized right from the start, such as long- and short-acting filgrastim biosimilars, are key to help manage the risk of serious complications related to infection," Sandoz global head of development, biopharmaceuticals Mark Levick said. "The U.S. market is just beginning to benefit from biosimilars, as shown by the success of our filgrastim, the first approved biosimilar in the U.S. The submission of our pegfilgrastim biosimilar application is another step for us as we continue to lead the way in creating early and expanded patient access to life-changing biologics."

Sandoz said it is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

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