Accord BioPharma, the US specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology, and Central Nervous System (CNS) therapies, announced today that the US Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim).

ENNUMO is indicated in adults and pediatric 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 (Hematopoietic 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 the only company in the US offering 2 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 3 products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.

Chrys Kokino, President, Accord North America, said, "Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies. With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognise that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly, we are proud that we have and will continue to increase patient access to these critically important medicines."