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

Key Insights

• 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.