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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.

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