Prestige BioPharma announced this week that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for a proposed trastuzumab biosimilar, HD201. Prestige hopes to eventually sell the product under the name Tuznue.
Prestige BioPharma announced this week that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for a proposed trastuzumab biosimilar, HD201, referencing Herceptin. Prestige hopes to eventually sell the product under the name Tuznue.
Lisa S. Park, PhD, chief executive officer of Prestige, said in a statement announcing the application, “We are very pleased that EMA has initiated the review of the HD201 Marketing Authorization Application. It is a major step in our endeavor to become a global player focusing on biosimilars and innovative biologics. Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing.”
Data published ahead of the 2019 of the American Society of Clinical Oncology meeting highlight the development process for the proposed biosimilar; first, say researchers, analytical comparability in terms of physiochemical and biological properties was assessed for the proposed biosimilar and the EU- and US-licensed reference Herceptin.1
Next, a single-dose phase 1 trial assessed the pharmacokinetic (PK) equivalence between the biosimilar and the EU reference in healthy volunteers. This study showed, say the investigators, that HD201 is safe and well tolerated, and has comparable PK to the EU reference after a single-dose administration.
Following the phase 1 study, a randomized, double-blind, parallel group, multicenter phase 3 study was conducted in comparison with the EU-licensed reference in 500 patients with HER2-positive early breast cancer. According to the investigators, an analysis of a substudy from this phase 3 trial showed comparable results for the biosimilar and the EU reference.
Prestige is also preparing its hopeful launch of the biosimilar; in late 2018, Prestige announced that it had entered into a licensing agreement with Cipla Limited to distribute and market the biosimilar trastuzumab in some emerging markets. Earlier, Prestige announced a deal with Alvogen to commercialize the biosimilar in Central and Eastern Europe.
1. Hii J, Pivot X, Park LS, et al. HD201: analytical biocomparability and clinical trial progression of trastuzumab [published online May 26, 2019]. J Clin Oncol. doi: 10.1200/JCO.2019.37.15_suppl.e12505.