On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars. Udenyca is administered the day after a chemotherapy treatment to decrease incidence of infection due to febrile neutropenia. It is currently available in a pre-filled syringe formulation, which will continue to be available after the autoinjector launch. Denny Lanfear, CEO of Coherus, stated “The UDENYCA® autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment.” The commercial availability of the Udenyca autoinjector is currently planned for Q2 2023.
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