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Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing Amgen's NEULASTA. ARMLUPEG is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs and to increase survival rates in individuals with hematopoietic subsyndrome of acute radiation syndrome.
Lupin also announced last week that it has entered into an exclusive licensing agreement with Valorum Biologics for the commercialization of ARMLUPEG. Under the terms of the agreement, Valorum will be responsible for the commercialization and distribution of ARMLUPEG in the United States, and Lupin will be responsible for manufacturing and supply of the product and will receive an upfront license fee and a royalty payment on net sales.
There are currently six other FDA-approved biosimilars referencing NEULASTA: Biocon's FULPHILA (pegfilgrastim-jmdb), Amneal's FYLNETRA (pegfilgrastim-pbbk), Pfizer's NYVEPRIA (pegfilgrastim-apgf), Fresenius Kabi's STIMUFEND (pegfilgrastim-fpgk), Accord's UDENYCA (pegfilgrastim-cbqv), and Sandoz's ZIEXTENZO (pegfilgrastim-bmez).
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