FDA APPROVES PFIZER’S ONCOLOGY SUPPORTIVE CARE BIOSIMILAR, NYVEPRIA™ (PEGFILGRASTIM-APGF)

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June 11, 2020: Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 NYVEPRIA is indicated 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.2

“The FDA approval of NYVEPRIA is a positive step that could both enable cost savings and increase access to an important treatment option,” said Andy Schmeltz, Global President, Pfizer Oncology. “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.”

The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

“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,” said Ali McBride, PharmD, MS, BCPS, BCOP, Immediate Past President of the Association of Community Cancer Centers (ACCC). “The FDA approval of NYVEPRIA provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”

Biosimilars play an important role in the treatment of cancer or as supportive care, with the ability to both help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. With more than a decade of global in-market experience, a portfolio of nine approved biosimilar products in the U.S. and the broadest biosimilar portfolio for oncology supportive care, Pfizer is proud to be a global leader in biosimilars and at the forefront of this vital healthcare segment. Pfizer has also filed its pegfilgrastim biosimilar candidate for regulatory approval with the European Medicines Agency (EMA) and the application is currently under review.

Pfizer is committed to ensuring that patients who are prescribed NYVEPRIA have access to this therapy. Upon launch, patients in the U.S. will have access to Pfizer Oncology Together™, which offers personalized support and financial assistance resources to help patients access their prescribed Pfizer Oncology medications. Pfizer Oncology Together can help patients understand their benefits and connect them with financial assistance resources, regardless of their insurance coverage.

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