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.

For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.



The author would like to thank April Breyer Menon for her contributions to this article.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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