Tanvex has received disappointing news on its US filing for a Herceptin (trastuzumab) biosimilar, with the US Food and Drug Administration issuing the firm with a complete response letter over its TX05 trastuzumab candidate.
The Taiwanese firm said the CRL for the breast cancer and gastric cancer treatment “cites certain issues to be addressed by the downstream manufacturer of TX05, which is a third-party service provider of Tanvex US for its drug product,” adding that “Tanvex US is proactively discussing with
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Generics Bulletin for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?