Accord BioPharma, the US specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology and central nervous system (CNS) therapies, has announced US Food and Drug Administration (FDA) approval for Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim).
Ennumo is indicated in adults and paediatric patients aged newborn and older 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, 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 is now said to be 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.
Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.
Expanding access through portfolio breadth
Febrile neutropenia is one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalisations, and increased mortality risk in patients with cancer. Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies across a range of clinical settings.
