Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.
Singapore-based Prestige Biopharma and a subsidiary of Teva Pharmaceutical Industries announced this week they reached a commercialization agreement for Prestige Biopharma’s trastuzumab biosimilar (HD201, Tuznue) in Israel.
The biosimilar referencing Roche’s Herceptin is used for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Currently, the European Medicines Agency (EMA) is reviewing a marketing authorization application for Tuznue based on positive data collected from global clinical trials comparing the biosimilar and the reference product.
Earlier this year, Prestige Biopharma shared results from 2 clinical trials demonstrating equivalent safety, pharmacokinetics, efficacy, immunogenicity, and tolerability of Tuznue in comparison with Herceptin at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
In TROIKA-I, 101 healthy individuals were randomized to either Tuznue or EU or US Herceptin products. They each received a single 6 mg/kg intravenous dose over a 90-minute infusion. TROIKA-I demonstrated that the biosimilar was safe and well tolerated with pharmacokinetics comparable with Herceptin.
The second study, TROIKA, compared safety, pharmacokinetics, and efficacy, based on the total pathological complete response rate in a randomized, double-blind, multicenter phase 3 trial. Patients were given Tuznue or EU-Herceptin in combination with chemotherapy in the neoadjuvant setting followed by trastuzumab monotherapy in the adjuvant phase. There were 574 patients evaluable for response.
Investigators said 46.6% of patients in the Tuznue arm achieved complete response versus 46.2% of patients in the Herceptin arm; 55.0% of patients achieved breast pathological CR in the Tuznue arm versus 53.4% in the Herceptin arm; and the overall response rate was 90.8% versus 89.4%, respectively. These results all demonstrated equivalence between the biosimilar and reference products; in addition, pharmacokinetics trough levels met the predefined equivalency margins and adverse events between the biosimilar and the reference were similar.
Under the partnership, the subsidiary, Teva Israel, will be responsible for the commercialization of the biosimilar in Israel as well as local regulatory registration, sales, and marketing. Prestige Biopharma will be in charge of EMA regulatory registration and getting commercial supply of Tuznue from its manufacturing facilities in Osong, Republic of Korea to Teva Israel’s facilities in Petah Tikva, Israel.
Last year, Prestige Biopharma struck agreements for Tuznue with 2 other companies: Pharmapark LLC for commercialization in Russia, and Mundipharma for commercialization in France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland, and Austria.
In addition to Tuznue, Prestige Biopharma is also developing biosimilars referencing bevacizumab (Avastin), adalimumab (Humira), denosumab (Prolia), aflibercept (Eylea), pertuzumab (Perjeta), eculizumab (Soliris), and ipilimumab (Yervoy).