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FDA Approves Accord BioPharma’s Filgrastim Biosimilar

Feb 17, 2026

On 17 February 2026, Accord BioPharma announced it has received FDA approval for Filkri™, biosimilar to Amgen’s Neupogen® (filgrastim), for the same indications as the reference medicine.

There are multiple filgrastim biosimilars that have been approved by the FDA since Sandoz’s Zarxio® was first approved in March 2015, including Hospira’s Nivestym™ (filgrastim-aafi) (July 2018), Kashiv Biosciences/Amneal’s Releuko™ (filgrastim-ayow) (March 2022), and Tanvex BioPharma’s Nypozi™ (filgrastim-txid) (July 2024).