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Fresenius Kabi and Dr. Reddy’s Announce Rituxan® Biosimilar Zimrixby™ (rituximab-cdxx) FDA Approval

by Robert S. Schwartz, Ph.D.
August 5, 2026

On August 3, 2026, Fresenius Kabi and Dr. Reddy’s announced the FDA-approval of Zimrixby™ (rituximab-cdxx), a biosimilar of Genentech’s Rituxan® (rituximab).  Zimrixby™ is the fourth Rituxan® biosimilar approved in the U.S.  Truxima® (rituximab-abbs) was approved as the first interchangeable biosimilar of Rituxan® in July 2026 (previously reported Celltrion’s Truxima® Approved as First Interchangeable Rituxan® Biosimilar).

Fresenius Kabi and Dr. Reddy’s settled BPCIA litigation No. 1:23-cv-22485 (D.N.J.) with Genentech in April 2024 with an undisclosed launch date (previously reported Genentech and Dr. Reddy’s Settle BPCIA Litigation Against Proposed Rituxan Biosimilar DRL_RI).

According to Samsung Bioepis’s Q3 2026 Biosimilar Market Report, rituximab biosimilars have gained about 76% market share since launching in November 2019, with Truxima® and Ruxience® (rituximab-pvvr) each having about 35% market share.

Currently there are no pending patent disputes related to Rituxan® biosimilars.

Roche reported Rituxan® sales of 794 million CHF (approximately $983 million USD) in 2025.

For more information on these and other biosimilars, 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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