On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved reference indications.
According to the announcement, Accord is now the only company in the US offering two distinct pegfilgrastim biosimilars to Amgen’s Neulasta®, Ennumo™ (pegfilgrastim-pccg) and Udenyca® (pegfilgrastim-cbqv). Udenyca® was acquired by Intas Pharmaceuticals (Accord’s parent company) from Coherus Biosciences in August 2025.
There are a number of other pegfilgrastim biosimilars approved in the US, including Mylan/Biocon’s Fulphila® (approved June 2018, launched July 2018), Coherus/Accord’s Udenyca® (PFS approved November 2018, PFS launched January 2019; autoinjector approved March 2023, autoinjector launched May 2023; Udenyca OnBody® approved December 2023, launched February 2024), Sandoz’s Ziextenzo® (approved November 2019), Pfizer’s Nyvepria® (approved June 2020), Amneal/Kashiv’s Fylnetra™ (approved May 2022, launched May 2023), Fresenius’ Stimufend® (approved September 2022, launched February 2023) and Lupin’s Armlupeg™ (approved December 2025).