Prestige Biopharma has now formally withdrawn its European filing for its HD201 planned biosimilar rival to Herceptin (trastuzumab), following a negative opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use as well as a requested re-examination.
Prestige Pulls Trastuzumab After EMA Knockback
Formal Withdrawal Of MAA Follows CHMP Negative Opinion And Re-Examination
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a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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