Coherus Neulasta Biosimilar Autoinjector Gets FDA Approval

The US Food and Drug Administration has approved the use of an autoinjector version ofUdenyca Coherus Biosciences biosimilar to Amgen’s Neulasta, a drug that reduces the chance of developing febrile neutropenia after chemotherapy. While this is the first approved autoinjector version of the drug, it’s far from the only biosimilar.

According to Skylar Jeremias, “In addition to the 2 FDA-approved presentations for the biosimilar, another application for an on-body injector version is under review. According to Amgen, sales of originator Neulasta has been declining due to the market introduction of pegfilgrastim biosimilars. However, shares of Neulasta Onpro have been steady, achieving 58% of the pegfilgrastim market share during the second quarter of 2020.”

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(Source: AJMC Biosimilars, March 6^th, 2023)