FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Prestige Wins European Review for Breast, Esophageal Cancer Biosimilar

June 12, 2019

European regulators have agreed to review Prestige BioPharma’s application for a biosimilar to treat breast and esophageal cancers, the Singapore-based company announced.

HD201 is Prestige’s lead candidate as a biosimilar to Herceptin (trastuzumab), which has already been approved for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma and HER2-overexpress breast cancer.

Herceptin has been a blockbuster for Roche, with nearly $3 billion in U.S. sales last year alone. Its patent expires in a couple of weeks. Prestige says it has eight other biosimilars/biologics in its development pipeline.

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