On April 10, 2024, the Court granted Plaintiffs Genentech, Hoffmann-La Roche, and Biogen and Defendants Dr. Reddy’s and Fresenius Kabi’s joint stipulation of dismissal due to settlement in Case No. 1:23-cv-22485 (D.N.J.) related to Dr. Reddy’s and Fresenius Kabi’s proposed Rituxan^® (rituximab) biosimilar DRL_RI.

The Complaint, which was filed in November 2023, alleged infringement of 15 patents (See BPCIA Complaint Against Proposed Rituxan® Biosimilar DRL_RI Filed) by DRL_RI, which the subject of a pending aBLA, accepted by FDA in July 2023.  The parties have not publicly disclosed the terms of their settlement agreement.  This was the only pending patent proceeding related to a Rituxan^® biosimilar.

Once approved and launched, DRL_RI will join three other Rituxan^® biosimilars in the U.S. market, including Celltrion and Teva’s Truxima^® (rituximab-abbs), Pfizer’s Ruxience^® (rituximab-pvvr), and Amgen and Allergan’s Riabni™ (rituximab-arrx).

Rituxan^® had worldwide sales of approximately $1.78 billion USD in 2023.

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