FDA Approves Pegfilgrastim Biosimilar ENNUMO for the Prevention of Febrile Neutropenia and Treatment of Acute Radiation Syndrome

Clinical Summary: 

• The FDA approved ENNUMO (pegfilgrastim-pccg), a biosimilar to pegfilgrastim, for the same indications as the reference product in adults and pediatric patients requiring granulocyte colony-stimulating factor (G-CSF) support.
• ENNUMO is approved to reduce the incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy for non-myeloid malignancies and to increase survival following myelosuppressive radiation exposure. The approval expands the availability of pegfilgrastim biosimilars for supportive oncology care.
• ENNUMO provides an additional pegfilgrastim biosimilar option that may broaden access to G-CSF supportive care for patients receiving myelosuppressive cancer treatment.

The US Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg; Accord BioPharma), a biosimilar to pegfilgrastim (Neulasta), for the same approved indications as the reference product. ENNUMO is indicated to reduce the incidence of febrile neutropenia in adults and pediatric patients receiving myelosuppressive chemotherapy for non-myeloid malignancies associated with a clinically significant risk of febrile neutropenia and to increase survival following myelosuppressive radiation exposure.

The approval expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) biosimilar portfolio to include two pegfilgrastim biosimilars—ENNUMO and UDENYCA (pegfilgrastim-cbqv) —alongside the short-acting filgrastim biosimilar FILKRI (filgrastim-laha), which received FDA approval earlier this year. According to the company, the expanded portfolio is intended to provide clinicians with multiple G-CSF biosimilar options across a range of oncology practice settings.

Febrile neutropenia remains a common complication of myelosuppressive chemotherapy and is associated with treatment delays, dose reductions, hospitalization, and increased mortality risk. G-CSFs are an established component of supportive cancer care, and biosimilars continue to expand access to these therapies.

The prescribing information for ENNUMO includes a contraindication for patients with a history of serious hypersensitivity reactions to pegfilgrastim or filgrastim products. Warnings and precautions include splenic rupture, acute respiratory distress syndrome, serious hypersensitivity reactions, sickle cell crises, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential stimulation of malignant cell growth, myelodysplastic syndrome and acute myeloid leukemia in certain patients with breast and lung cancer, aortitis, and effects on bone imaging. The most commonly reported adverse reactions are bone pain and pain in an extremity.

“Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," stated Chrys Kokino, President, Accord North America. "With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company."

Source: 

Accord BioPharma. FDA approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's second pegfilgrastim biosimilar to NEULASTA® (pegfilgrastim). Accessed on July 13, 2026. https://www.accordbiopharma.com/news/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim/