News Briefs: Fresenius Kabi Launches First Actemra Biosimilar

May 09
May 09, 2024

Fresenius Kabi AG launched Tyenne (tocilizumab-aazg), the first biosimilar of Roche Group member Genentech USA, Inc.’s Actemra (tocilizumab) to become available in the U.S., the company revealed April 15. The FDA approved the interleukin-6 inhibitor on March 5 in both intravenous and subcutaneous formulations, making it the only Actemra biosimilar approved so far in both. On Sept. 29, 2023, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) as an intravenous formulation only. Fresenius says Tyenne is available now in an intravenous formulation. The agents are approved for several autoimmune conditions.

Sandoz reached an agreement with Amgen Inc. resolving all patent litigation related to denosumab, Sandoz revealed April 30. The FDA approved Sandoz’s Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) on March 5 as biosimilar to and interchangeable with Amgen’s Prolia (denosumab) and Xgeva (denosumab) for all of their indications. They are the first FDA-approved denosumab biosimilars. The agreement will allow the agents to launch on May 31, 2025, or earlier “under certain circumstances if customary acceleration provisions are triggered.”
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.