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News

FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)

by Robert S. Schwartz, Ph.D.
January 26, 2025

On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab).  Avtozma® is indicated for the treatment of multiple diseases including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus disease (COVID-19).  The FDA approved Biogen / Bio-Thera’s Tofidence™ (tocilizumab-bavi) in September 2023 and Fresenius Kabi’s Tyenne® (tocilizumab-aazg) in March 2024.  Tyenne® launched in April 2024 and Tofidence™ launched in May 2024.

Celltrion previously challenged two of Chugai and Genentech’s patents at the PTAB: U.S. Patent Nos. 8,580,264 (method of treatment claims) and 10,874,677 (drug delivery device claims) in IPR2022-00578 and IPR2022-00579 respectively.  The PTAB found all the challenged claims unpatentable in Final Written Decisions.  Chugai and Genentech voluntarily dismissed the appeals, stating they were no longer pursuing the appeals.  Celltrion has not yet announced a launch date for Avtozma®.

There are currently no pending patent disputes related to Actemra® biosimilars.

Roche reported U.S. sales of approximately $1.476B USD (1.331B CHF) for Actemra® in 2024.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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

 

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    Pharma Drug Biosimilar Biologic Research Laboratory Injection TN2

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). 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 (www.fda.gov). 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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