On 7 May 2026, the US Food and Drug Administration (FDA) approved Ennumo (pegfilgrastim-pccg), a biosimilar referencing Amgen’s blockbuster Neulasta. The approval adds an eighth competitor to the US pegfilgrastim biosimilar landscape, further intensifying pricing pressures in the supportive oncology care market.
Ennumo is developed by Accord BioPharma Inc, the US specialty division of India’s Intas Pharmaceuticals. The product leverages technology transferred from South Korea’s SunBio, which supplies the high-quality polyethylene glycol derivative essential to the drug’s manufacturing process. Under the terms of their agreement, SunBio stands to receive milestone payments tied to this approval and ongoing royalties on US net sales.
Accord has already established a strong presence for pegfilgrastim biosimilars in Europe, where it was the first to commercialise a biosimilar version and remains the only company offering an autoinjector device. Intas further consolidated its global leadership position in this class with the August 2025 acquisition of Udenyca (pegfilgrastim-cbqv) from Coherus BioSciences [1].
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It stimulates the production of white blood cells (neutrophils). Pegfilgrastim treatment is used to encourage bone marrow to produce more neutrophils to help fight infection in patients undergoing chemotherapy [2].
The FDA’s approval was supported by a comprehensive comparability exercise, demonstrating that Ennumo is highly similar to Neulasta with no clinically meaningful differences in purity, potency, or safety.
The product is supplied as a 6 mg/0.6 mL single-dose prefilled syringe for manual subcutaneous injection.
Ennumo is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive agents. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation for the treatment of Hematopoietic Subsyndrome of Acute Radiation Syndrome. The biosimilar is not indicated for stem cell mobilisation. Notably, Ennumo has not been granted interchangeability status, meaning it cannot be substituted for Neulasta at the pharmacy level without prescriber involvement.
The prescribing information carries notable warnings, including risks of fatal splenic rupture, acute respiratory distress syndrome, serious hypersensitivity reactions, sickle cell crises, glomerulonephritis, and aortitis. The most commonly reported adverse reactions occurring at an incidence at least 5% greater than placebo are bone pain and pain in the extremities.
With Ennumo’s approval, the FDA has now cleared eight biosimilars referencing Neulasta, joining Fulphila, Ziextenzo, Nyvepria, Udenyca, Fylnetra, Stimufend, and Armlupeg.
The entry of Ennumo is poised to deliver significant cost savings for cancer patients and healthcare systems while reinforcing Accord BioPharma’s growing portfolio of supportive-care biosimilars. As the pegfilgrastim market becomes increasingly saturated, biosimilar developers will likely pivot toward differentiation through device innovation and competitive contracting.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Coherus exits the biosimilars market with sale of Udenyca to Intas Pharmaceuticals [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 3]. Available from: www.gabionline.net/pharma-news/coherus-exits-the-biosimilars-market-with-sale-of-udenyca-to-intas-pharmaceuticals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
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