The EMA Rejects Prestige BioPharma’s Tuznue and Hervelous, a proposed biosimilars of trastuzumab for HER2-Positive Breast and Gastric Cancers
Shots:
- The EMA’s CHMP has issued an opinion recommending the refusal of marketing authorization for Tuznue and Hervelous, a proposed biosimilar of Roche’s Herceptin to treat HER2+ breast & gastric cancer
- The CHMP stated that the Tuznue manufacturing process used in clinical testing was not the same as the process used in commercial production. The CHMP concluded that the studies did not provide enough evidence to show that the biosimilar candidate would be bioequivalent to the reference trastuzumab
- The biosimilar was to be marketed as Hervelous in Belgium and Tuznue in the other EU member nations. The company plans to apply for a re-examination of HD201 to the EMA within 15 days of receiving the opinion
Ref: Koreabiomed | Image: Prestige BioPharma's
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