On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an Actemra® biosimilar, following Biogen and BioThera’s Tofidence™ (tocilizumab-bavi), approved by the FDA in September 2023, and Fresenius Kabi’s MSB11456 (tocilizumab), accepted by the FDA in August 2022.
Celltrion previously challenged Genentech’s U.S. Patent No. 8,580,264 (“the ’264 patent”) in IPR2022-00578, and U.S. Patent No. 10,874,677 (“the ’677 patent”) in IPR2022-00579. In August 2023, the PTAB issued Final Written Decisions in these IPRs finding method of treatment claims 1-12 of the ’264 patent and drug delivery device claims 1-8 of the ’677 patent unpatentable. Genentech has appealed both decisions (Federal Circuit Appeal Nos. 24-1111 and 24-1115).
To date no litigations related to CT-P47 have been filed. The sole litigation related to an Actemra® biosimilar filed to date, Case No. 1:23-cv-11573 (D. Mass.) against Biogen and BioThera related to Tofidence™, ended in a confidential settlement agreement in October 2023.
Roche reported that half-year U.S. 2023 sales of Actemra® were $629M.
We continue to monitor this aBLA. For more information on pending aBLAs and biosimilar patent disputes, please visit BiologicsHQ.
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The author would like to thank April Breyer Menon for her contributions to this article.
