Biosimilars in the United States: Current Status and Future Implications
Biosimilars in the United States: Current Status and Future Implications
June 11, 2020
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FDA approves Nyvepria, biosimilar to pegfilgrastim, to reduce infections

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The FDA approved pegfilgrastim-apgf, a biosimilar intended to reduce infection incidence among certain patients with cancer.

Pegfilgrastim-apgf (Nyvepria, Pfizer) — a biosimilar to pegfilgrastim (Neulasta, Amgen) — is indicated to reduce infections manifested by febrile neutropenia among patients who receive nonmyelosuppressive anticancer drugs such as chemotherapy that can cause fever and low white blood cell count.

“Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens,” Ali McBride, PharmD, MS, BCPS, BCOP, immediate past president of Association of Community Cancer Centers, said in a Pfizer-issued press release. “The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

A biosimilar is a biological product — which is derived from a living organism such as humans, animals, microorganisms or yeast — that is approved based on data showing it is highly similar to an already-approved biological product. The biosimilar must show no clinically meaningful differences in safety, purity and potency from its reference product.

“The FDA approval of Nyvepria is a positive step that could both enable cost savings and increase access to an important treatment option,” Andy Schmeltz, global president of Pfizer Oncology, said in the release. “We are proud to add this new, long-acting supportive care option to our robust portfolio, now with six FDA-approved oncology biosimilars, including three specifically approved for supportive care for patients with cancer. We look forward to making Nyvepria available to U.S. patients and physicians later this year.”