Prestige BioPharma Reports EMA’s Acceptance of Marketing Authorization Application for its Tuznue (trastuzumab, biosimilar)

 Prestige BioPharma Reports EMA’s Acceptance of Marketing Authorization Application for its Tuznue (trastuzumab, biosimilar)

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