On October 23, 2023, Plaintiffs Genentech, Chugai, and Hoffmann-La Roche and Defendants Biogen and Bio-Thera filed a stipulation of dismissal in Case No. 1:23-cv-11573 (D. Mass.) due to settlement.  The BPCIA litigation was filed in July 2023 (complaint), after the parties engaged in the BPCIA patent dance, alleging that the commercial manufacture, use, offer for sale, and/or sale, or import into the United States of Tofidence™ (tocilizumab-bavi) would infringe 20 of Plaintiffs’ patents included on the parties’ lists exchanged during the patent dance.  The complaint did not allege that Defendants had given 180-day marketing notice by the time of filing.

The stipulated dismissal can be found here.  The details of the settlement agreement have not been made public.

Subsequent to the filing of the litigation, the FDA approved Tofidence as biosimilar to Genentech’s Actemra® (tocilizumab) on September 29, 2023.  Tofidence is currently the only FDA approved biosimilar to Actemra.  However, Fresenius Kabi’s aBLA for MSB11456 was accepted by the FDA in August 2022 and is currently pending.  Fresenius Kabi previously settled IPRs against six of Chugai and Hoffmann-La Roche’s patents relating to its proposed biosimilar in October 2022.  While an aBLA filing has not yet been announced for CT-P47 under development by Celltrion, the PTAB issued final written decisions in Celltrion’s IPRs in August 2023, invalidating all challenged claims of two of Genentech, Chugai, and Hoffmann-La Roche’s patents.

For more details on the patents involved in this litigation and IPRs related to Actemra, please visit BiologicsHQ.



The author would like to thank April Breyer Menon for her contribution 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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