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Tanvex Biopharma Receives Second CRL from FDA for Herceptin Biosimilar TX-05

• Tanvex Biopharma U.S.A. Inc. received a second Complete Response Letter (CRL) from the FDA on January 3 for its TX-05 Biologics License Application (BLA). • The CRL identifies issues that must be resolved by the third-party manufacturer responsible for producing Tanvex's TX-05 drug product. • TX-05 is a biosimilar referencing Roche's Herceptin (trastuzumab), a medication used in the treatment of HER2-positive breast cancer and gastric cancer.

Tanvex Biopharma Inc. has announced that its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 3 regarding its Biologics License Application (BLA) for TX-05, a biosimilar referencing Roche's Herceptin (trastuzumab). This marks the second CRL issued for TX-05.
The FDA's CRL cites issues that need to be addressed by the downstream manufacturer of TX-05. The manufacturer is a third-party service provider responsible for the drug product's production.
Herceptin (trastuzumab) is a monoclonal antibody targeting the HER2 receptor, widely used in treating HER2-positive breast cancer and gastric cancer. Biosimilars like TX-05 aim to provide more affordable treatment options, expanding access to these life-saving therapies.
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Reference News

[1]
Taiwan's Tanvex receives second CRL for Herceptin biosimilar
bioworld.com · Jan 6, 2025

Tanvex Biopharma Inc.'s U.S. subsidiary received an FDA complete response letter for its TX-05 BLA, a Herceptin biosimil...

[2]
Taiwan's Tanvex receives second CRL for Herceptin biosimilar
bioworld.com · Jan 7, 2025

Tanvex Biopharma's U.S. subsidiary received an FDA CRL on Jan. 3 for its TX-05 BLA, a Herceptin biosimilar, citing issue...

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