Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA
Tuznue And Hervelous Rivals To Herceptin Receive Negative Opinions From CHMP
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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Prestige says a meeting with the FDA in November represents a “final step” before filing its trastuzumab biosimilar with the US agency by the end of the year. Meanwhile, a major shareholder has invested further in the Singapore-based biosimilars developer.
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.
Prestige Biopharma says it is acting to “consolidate group competitiveness” by taking an increased share in Prestige Biologics, at the same time as a new CEO was appointed for the CDMO.