Pfizer gets FDA OK for biosimilar Neulasta

Cancer patients will soon have a biosimilar treatment to help decrease the incidence of infection from certain anti-cancer drugs, such as chemotherapy.

Pfizer has obtained the Food and Drug Administration’s blessing for Nyvepria (pegfilgrastim-apgf), a biosimilar to Amgen’s Neulasta (pegfilgrastim).

Nyvepria helps to reduce the chance of infection due to a low white blood cell count in people with non-myeloid cancer who receive anti-cancer medicines, like chemotherapy, that can cause fever and low white blood cell count. This condition, known as febrile neutropenia, is a common side effect of many types of chemotherapy and lowers the body’s ability to defend itself against infections.

“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, Pfizer oncology global president. “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.”

“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, immediate past president of the Association of Community Cancer Centers. "The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”