On March 5, 2024, the FDA approved Fresenius Kabi's Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche's Actemra® (tocilizumab). This is the second Actemra® biosimilar to be approved in the U.S., following the approval of Biogen and Bio-Thera's Tofidence™ (tocilizumab-bavi) in September 2023, but it is the first biosimilar to be approved with both an intravenous and subcutaneous formulation. Celltrion has a pending aBLA for its proposed Actemra®biosimilar, CT-P47.
Fresenius Kabi previously settled its seven IPRs filed against Chugai patents in October 2022, with a confidential launch date for Tyenne®. As we previously reported, the voluntary dismissals of the remaining two pending Actemra®biosimilar disputes, CAFC Appeal Nos. 24-1111 and 24-1115 of the Final Written Decisions in IPR2022-00578 and IPR2022-00579 filed by Celltrion finding all of the challenged claims of Chugai, Genentech and Hoffman-La Roche's U.S. Patent No. 8,580,264 and U.S. Patent No. 10,874,677 unpatentable, were granted on March 6, 2024 (See Chugai, Genentech, and Hoffmann-La Roche Dismiss Appeals of Actemra® Patent IPR Final Written Decisions).
Roche reported worldwide sales of Actemra® in 2023 were approximately $3 billion USD.
The author would like to thank April Breyer Menon for her contributions to this article.
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