Tanvex’s US trastuzumab biosimilar TX05 has drawn a third FDA complete response letter, with the latest setback again tied to its third-party downstream manufacturer rather than the biosimilar’s drug substance.
Tanvex’s US trastuzumab biosimilar TX05 has drawn a third FDA complete response letter, with the latest setback again tied to its third-party downstream manufacturer rather than the biosimilar’s drug substance.