On February 8, 2023 Prestige Biopharma, a Singapore-based biopharmaceutical company, reported the publication of ‘Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting’ in ‘BMC (BioMed Central) Cancer’ (Press release, Prestige BioPharma, FEB 8, 2023, View Source [SID1234626961]). HD201 (Tuznue) is the company’s Herceptin biosimilar. Based on the final analysis of phase 3 clinical trial, the company plans to expedite the preparation for BLA submission to US FDA (Food and Drug Administration).

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BMC cancer is a peer-reviewed open access medical journal that publishes original research on cancer and oncology. Following the previous analysis at a median follow-up of 31 months, this final analysis has compared long-term survival rates at a median follow-up of 37.7 months, confirming the comparable efficacy and safety of HD201 and trastuzumab. The publication of the final analysis was led by professor Xavier Pivot who took charge of the clinical trial of Roche’s Herceptin and Samsung Bioepis’ Herceptin biosimilar.

The global phase 3 clinical trial of HD201 was carried out from February 2018 to January 2022 in 12 countries for a total of 502 HER2 positive cancer patients who randomly received treatment with either HD201 or referent trastuzumab. According to the final analysis, which was performed after all patients completed the study at a median follow-up of 37.7 months, HD201 has shown excellence in long-term efficacy and safety. The 3-year event-free survival (EFS) rates were 85.6% and 84.9% in the HD201 and referent trastuzumab groups, respectively, and the 3-year overall survival (OS) rates were 95.6% and 96.0%, confirming comparability of HD201 and the referent trastuzumab.

Prestige Biopharma has previously supported the excellence of HD201 through several publications of studies and analysis. In July 2021, the company published a bridging study in ‘Pharmacology Research & Perspectives’ equivalent pharmacokinetic and safety profile to both US-Herceptin and EU- Herceptin. In March 2022, the company’s publication of phase 3 clinical trial analysis in ‘JAMA Oncology’ highlighted comparative efficacy and safety of HD201 and the referent trastuzumab in terms of the total pathological complete response rates.

Lisa S. Park, CEO of Prestige Biopharma, commented: "This final analysis, based on the data that we have been accumulated over the past three years, has once again proved the excellence of HD201, being published in a reputable journal in the field of oncology. Confident with high comparability with the original drug, efficient production through our affiliate company Prestige Biologics, and past experience in applying for marketing authorization to EMA, we will focus on getting the marketing authorization for HD201 in various regions including US, Europe, Canada, and Korea as soon as possible."