Prestige Bio Withdraws Application for Herceptin Biosimilar Marketing Authorization in Europe
[Asia Economy Reporter Choi Seoyoon] Prestige BioPharma, a biopharmaceutical development company, announced on the 15th that it has voluntarily withdrawn its application for re-examination of the marketing authorization for the anticancer drug 'Herceptin' biosimilar 'HD201' submitted to the European Medicines Agency (EMA).
HD201 is a biosimilar drug developed by Prestige BioPharma. It is used for breast cancer and metastatic gastric cancer, among others.
Prestige BioPharma first applied for marketing authorization of HD201 to the EMA in 2019. However, in May of this year, it received a 'negative opinion' from the Committee for Medicinal Products for Human Use (CHMP) under the EMA, and four days later, the company applied for a re-examination.
Prestige BioPharma stated that it will verify additional analytical test methods and supplement the data before reapplying for marketing authorization review.
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Prestige BioPharma also plans to apply for marketing authorization from the U.S. Food and Drug Administration (FDA).
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