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Prestige Pulls Trastuzumab After EMA Knockback

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

 
• By Dave Wallace

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a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

Withdrawal wooden blocks letters
Prestige has withdrawn its HD201 trastuzumab candidate in Europe • Source: Shutterstock

Prestige Biopharma has now formally withdrawn its European filing for its HD201 planned biosimilar rival to Herceptin (trastuzumab), following a negative opinion from the European Medicines Agency’s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.

The company said it was planning to “reapply to EMA for the marketing authorization application with

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