On December 26, 2023, Coherus Biosciences announced the end of its long journey to bring competition to the full pegfilgrastim product line. The FDA has approved its on-body injection formulation to compete with Amgen’s Neulasta OnPro®.
In Coherus’ press release, Danny Lanfear, CEO, stated, “The on-body injector for Udenyca is the result of years of significant investment in research and development to bring forward a novel and proprietary on-body device that provides patients with an automatic delivery option for their medication. Cancer patients and their physicians will now be able to choose the Udenyca administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”
Udenyca Onbody uses a proprietary injector; this device is not considered a “biosimilar” of OnPro, even though Udenyca is biosimilar to Neulasta. Coherus believes that its own on-body injector will be as well accepted as OnPro, and is in some ways able to provide a better patient experience.
Coherus said that marketing of the on-body injector will begin in the first quarter of 2024. Despite the approval of the first pegfilgrastim biosimilars in 2018, Neulasta OnPro still retains the greatest marketshare, with slightly less than half of the overall category utilization. With this approval, Coherus has the opportunity to be the first to challenge Amgen for dominance in the category. Udenyca, Fulphila®, Ziextenzo®, and Neulasta have approximately equal shares of the prefilled syringe market.
