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EMA Accepts Application for Trastuzumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Wednesday, May 29, 2019

Lisa S. Park

Lisa S. Park

The European Medicines Agency (EMA) has validated and accepted a marketing authorization application for the trastuzumab (Herceptin) biosimilar HD201 (Tuznue), according to the developer Prestige BioPharma.

Four trastuzumab biosimilars have been approved in the United States. Most recently, in March 2019, the FDA approved PF-05280014 to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or GEJ adenocarcinoma. Additional FDA-approved trastuzumab biosimilars include CT-P6, SB3, and MYL-1401O (Ogivri; trastuzumab-dkst).


  1. Pivot X, Deslypere JP, Park LS, et al. A randomized phase I study comparing the pharmacokinetics of HD201, a trastuzumab biosimilar, with European Union-sourced Herceptin. Clin Ther. 2018;40(3):396-405. doi: 10.1016/j.clinthera.2018.01.009.
  2. Hii J, Pivot X, Park LS, et al. HD201: analytical biocomparability and clinical trial progression of trastuzumab. J Clin Oncol. 2019;37 (suppl; abstr e12505).

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