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Genentech and Dr. Reddy’s Settle BPCIA Litigation Against Proposed Rituxan Biosimilar DRL_RI

by Robert S. Schwartz, Ph.D.
April 15, 2024

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.

For more information on this and other biosimilar litigations, please visit BiologicsHQ.com.

 

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

    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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