Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA
Tuznue And Hervelous Rivals To Herceptin Receive Negative Opinions From CHMP
Executive Summary
Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.