Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar

Korea Biomedical Review

16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving HD201 (Tuznue), a biosimilar referencing Herceptin to treat breast cancer and metastatic gastric cancer.

The withdrawal comes after the company received a negative opinion on the marketing authorisation for HD201 from the EMA's CHMP on May 19.

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Michael Wonder

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Michael Wonder