Accord BioPharma, the US specialty division of India-based Intas Pharmaceuticals Ltd, focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced on Thursday that the US Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim).

ENNUMO is indicated in adults and paediatric patients aged newborn and older to reduce 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, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Haematopoietic Subsyndrome of Acute Radiation Syndrome). ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

With this approval, Accord BioPharma says it is now the only company in the US offering two distinct pegfilgrastim biosimilars -- ENNUMO and UDENYCA (pegfilgrastim-cbqv) -- alongside FILKRI (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026.

The company has set a strategic goal to launch 20 biosimilar products in the United States by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies.