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Prestige Pulls Trastuzumab After EMA Knockback

Formal Withdrawal Of MAA Follows CHMP Negative Opinion And Re-Examination

Executive Summary

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a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.

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