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.
Reference
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.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.