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Tanvex Receives Third CRL for Proposed Herceptin® Biosimilar TX-05

by Robert S. Schwartz, Ph.D.
June 27, 2026

On June 23, 2026, Tanvex received a Complete Response Letter (“CRL”) from the FDA for its proposed Herceptin® (trastuzumab) biosimilar TX-05 (trastuzumab), after resubmitting its application in December 2025.  This is the third CRL Tanvex has received for TX-05.  The CRL did not raise deficiencies with the drug substance but found inspection issues with the downstream fill/finish facility.  Tanvex plans to submit a response to the FDA in July.

Genentech previously brought a BPCIA litigation against Tanvex, Case No. 3:22-cv-00809 (S.D. Cal.), alleging infringement of three of its patents by TX-05 that settled in February 2023.

The FDA has approved six Herceptin® biosimilars beginning in December 2017.  Trastuzumab biosimilars entered the U.S. market in July 2019, and according to Samsung Bioepis’s Q2 2026 Biosimilar Market Report, have about 89% market share.

There are currently no pending patent disputes related to Herceptin® biosimilars.

Roche reported sales of 225 million CHF (approximately $279 million USD) for Herceptin® in 2025.

For more information on these biosimilars 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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