The European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Prestige BioPharma’s trastuzumab biosimilar, Tuznue (HD201).
The MAA has been validated and accepted for review, meaning that Prestige’s lead development candidate biosimilar to Roche’s Herceptin is one step closer to being indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The review would put Tuznue in the race along with Celltrion’s Herzuma, Amgen’s Kanjinti, MSD’s Ontruzant, and Pfizer’s Trazimera to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin.
Prestige are “very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application”.
Dr Lisa S. Park, chief executive of Prestige, said that it is a “major step in our endeavor to become a global player focussing on biosimilars and innovative biologics. Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing.”
HD201 is Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorisation from the EMA.
Prestige also announced that based on the achievement, it will continue to move forward with other eight biosimilars and innovative biologics in its portfolio, which are currently at different stages of development, from nonclinical development to advanced clinical stages.