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Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Tuznue And Hervelous Rivals To Herceptin Receive Negative Opinions From CHMP

 
• By Dave Wallace

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.

EU flag thumbs down
The CHMP has refused to endorse Prestige Biopharma’s trastuzumab • Source: Shutterstock

Prestige Biopharma has been frustrated in its efforts to win a European approval for its HD201 biosimilar rival to Herceptin (trastuzumab), after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued negative opinions recommending the refusal of marketing authorization applications submitted for the product under the Tuznue and Hervelous labels.

While Prestige did not immediately respond to Generics Bulletin enquiries over the next steps for the application, the CHMP noted that “Prestige Biopharma Belgium, the company that applied for the authorization, may ask

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