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Celltrion’s Truxima® Approved as First Interchangeable Rituxan® Biosimilar

by Robert S. Schwartz, Ph.D.
July 3, 2026

On July 1, 2026, Celltrion announced that the FDA designated Truxima® (rituximab-abbs) as interchangeable with Genentech’s Rituxan® (rituximab).  Truxima® was first approved as a biosimilar in November 2018 and is the first Rituxan® biosimilar to receive an interchangeable designation.  As the first interchangeable, Truxima® has secured interchangeable regulatory exclusivity.  With the interchangeable designation, Truxima® can be automatically substituted at the pharmacy level, subject to state laws.

Truxima® was first launched in the U.S. in November 2019, and according to Samsung Bioepis’s Q2 2026 Biosimilar Market Report, it has gained approximately 31% market share, trailing Pfizer’s Ruxience® (rituximab-pvvr), which has obtained approximately 39% 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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