Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)
Shots:
- The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer
- The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile, safety & immunogenicity among healthy volunteers & HER2+ve early breast cancer patients, respectively
- In addition, Prestige has already entered into licensing agreements with Dr. Reddy’s, Tabuk, Cipla & Pharmapark for its marketing & sales worldwide, triggering milestone payments; negotiations are ongoing for market entry across the EU
Ref: Prestige Biopharma | Image: Prestige Biopharma
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
