Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, announced that the FDA has approved ENNUMO (pegfilgrastim‑pccg), a biosimilar to Neulasta (pegfilgrastim), for use in adults and pediatric patients from birth and older.
ENNUMO is approved to reduce the incidence of infection, manifested as febrile neutropenia, in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant risk of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation in the setting of the hematopoietic subsyndrome of acute radiation syndrome. The biosimilar carries the same indications as its reference product.
With this approval, Accord BioPharma now offers two distinct pegfilgrastim biosimilars in the U.S. — ENNUMO and UDENYCA (pegfilgrastim‑cbqv) — together with FILKRI (filgrastim‑laha), a short‑acting granulocyte colony‑stimulating factor (G‑CSF) biosimilar approved earlier in 2026. The three products form a G‑CSF portfolio intended to address varying clinical and operational needs in oncology practices and hospital settings.
Febrile neutropenia remains a common and serious complication of myelosuppressive chemotherapy, often leading to treatment delays, dose modifications, hospitalizations, and increased mortality risk. Long‑acting and short‑acting G‑CSF therapies are widely used to reduce these risks, and biosimilars are increasingly adopted to support broader access and potential cost savings.
Accord BioPharma said it plans to continue expanding its biosimilar portfolio, with a goal of bringing additional products to market by 2030.
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