Prestige BioPharma Reports EMA’s Acceptance of Marketing Authorization Application for its Tuznue (trastuzumab, biosimilar)
Shots:
- Prestige Biopharma announces that EMA has accepted & validated MAA for its Tuznue, a biosimilar to Herceptin (trastuzumab) on May 23, 2019
- Prestige’s Tuznue will be in competition with Celltrion’s Herzuma, Amgen’s Kanjinti, Merck Sharp & Dohme’s Ontruzant & Pfizer’s Trazimera in the European market, dominated by Roche’s Herceptin
- Tuznue (HD201) is currently evaluated in P-I/P-III global studies and has received CHMP’s positive opinion for marketing authorization from the EMA. Additionally, Prestige has 8 biosimilar & biologics in its portfolio which are at different development stages
Click here to read full press release/ article | Ref: Prestige BioPharma | Image: Sigitech Holdings