On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form. Just days later, on 4 December 2025, Lupin also announced that it entered into an exclusive licensing agreement with Valorum Biologics for the US commercialisation of Armlupeg™.
Under the terms of the licence agreement, Valorum will be the responsible for commercialisation and distribution of Armlupeg™, while Lupin will be responsible for manufacturing and supply of the product and will receive an upfront licence fee and a royalty payment on net sales.
There are a number of other pegfilgrastim biosimilars approved in the US, including Biocon’s Fulphila® (June 2018), Coherus/Accord’s Udenyca® (November 2018), Sandoz’s Ziextenzo® (November 2019), Pfizer’s Nyvepria® (June 2020), Amneal/Kashiv’s Fylnetra™ (May 2022), and Fresenius’ Stimufend® (September 2022).
The US approval of Armlupeg™ follows approval by Health Canada in August 2024 for the same presentation.