FDA Approves Ennumo, the Eighth Neulasta Biosimilar, for Supportive Cancer Care

The FDA has approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), for adults and children. Developed by Accord BioPharma, it is the eighth pegfilgrastim biosimilar approved in the United States. The drug is supplied as a single-dose prefilled syringe and helps reduce the risk of infection by increasing white blood cell production in patients receiving chemotherapy. It is also approved to improve survival after exposure to high doses of radiation that damage the bone marrow.

Ennumo should not be used in patients with severe allergic reactions to pegfilgrastim or filgrastim products. Important safety warnings include the risk of spleen rupture, acute respiratory distress syndrome, capillary leak syndrome, kidney problems, and abnormal blood cell counts. Although Ennumo is highly similar to Neulasta in safety and effectiveness, it is not approved as an interchangeable biosimilar, meaning pharmacists cannot automatically substitute it without a healthcare provider’s prescription.

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