EMA Accepts Prestige BioPharma’s Trastuzumab Biosimilar MAA for Review

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Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

Prestige BioPharma, a Singapore-based biopharmaceutical company, has announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) for its trastuzumab biosimilar HD201 (Tuzune) for review.

“We are very pleased that EMA has initiated the review of the HD201 MAA. It is a major step in our endeavor to become a global player focusing on biosimilars and innovative biologics,” said Dr. Lisa S. Park, chief executive officer of Prestige in a May 28, 2019 press release. “Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing.”

HD201 is the company’s lead development candidate biosimilar to Herceptin and is the first for the company to receive a positive opinion from the Committee for Medicinal Products for Human Use. If approved by EMA, HD201 will join other trastuzumab biosimilars in the EU market for the treatment of adult patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.


Prestige has filed for marketing authorization with the US FDA also and will continue to develop eight biosimilars and innovative biologics in its portfolio.

Source: Prestige BioPharma