Posted by Michael Wonder on 29 May 2019
European Medicines Agency accepts marketing authorisation application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review
28 May 2019 - Prestige BioPharma announced that EMA has validated and accepted for review the marketing authorisation application for its trastuzumab biosimilar HD201 (Tuznue) on 23 May 2019.
HD201 is Prestige’s lead development candidate biosimilar to Herceptin (trastuzumab), which is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Accordingly, if authorized by the EMA, HD201 (Prestige) would take part in the race along with Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Merck Sharp & Dohme), and Trazimera (Pfizer) to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin (Roche).
Furthermore, the positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.
