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: Prnewswire | Image: Prestige Biopharma | Press Release
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