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.