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On July 9, 2026, Accord BioPharma announced that the FDA approved ENNUMO (pegfilgrastim-pccg). ENNUMO references Amgen’s NEULASTA (pegfilgrastim). The FDA approved ENNUMO on May 7, 2026, for the same indications as NEULASTA: for adult and pediatric patients, to decrease the incidence of infections, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. ENNUMO will be supplied in a single-dose prefilled syringe.
Accord now has two FDA-approved pegfilgrastim biosimilars: ENNUMO and UDENYCA (pegfilgrastim-cbqv). First approved in November 2018, UDENYCA was originally developed by Coherus Biosciences and acquired by Accord in April 2025. UDENYCA is offered in three presentations: a prefilled syringe for manual injection, a single-dose autoinjector, and an on-body injector with a prefilled syringe. Unlike ENNUMO, UDENYCA allows for weight-based dosing below 6 mg/0.6 mL for pediatric patients weighing less than 45 kg.
In addition to ENNUMO and UDENYCA, Accord offers FILKRI (filgrastim-laha), referencing Amgen’s NEUPOGEN (filgrastim). Filgrastim and pegfilgrastim are both granulocyte colony-stimulating factors (G-CSFs), where pegfilgrastim has a polyethylene glycol molecule attached that allows for longer-lasting activity and reduced dosing frequency. According to Accord, it is now “the only company in the U.S. 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.”
With this approval, there are now eight biosimilars approved by the FDA that reference NEULASTA: ENNUMO, UDENYCA, Lupin’s ARMLUPEG (pegfilgrastim-unne), Biocon’s FULPHILA (pegfilgrastim-jmdb), Amneal’s FYLNETRA (pegfilgrastim-pbbk), Pfizer’s NYVEPRIA (pegfilgrastim-apgf), Fresenius Kabi’s STIMUFEND (pegfilgrastim-fpgk), and Sandoz’s ZIEXTENZO (pegfilgrastim-bmez).
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