Prestige BioPharma’s Tuznue, a proposed biosimilar to Herceptin Receives EU-GMP Certification for the Treatment of Gastric & Breast Cancer
Shots:
- Prestige’s manufacturing facility for Herceptin biosimilar, Tuznue has received EU GMP certification & gets the ability to commercialize the products in the EU for the treatment of HER2 positive breast and metastatic gastric cancer
- The results showed that Tuznue’s equivalence to Herceptin in two P-I trials conducted in the EU and Australia. The P-III trial results have been published in scientific journals and conferences
- Tuznue is currently under MAA review in EU EMA, Canada, and South Korea. Additionally, HD204 biosimilar to Avastin is being evaluated in the P-III clinical trial & the company is expected the filling to the US FDA and EMA in 2022
Ref: Businesswire | Image: Businesswire
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