Singapore-based Prestige Biopharma has secured a commercialization agreement with Teva Israel, a subsidiary of Teva Pharmaceutical Industries, for its trastuzumab biosimilar Tuznue (HD201) in the Israeli market. The biosimilar references Roche's blockbuster cancer therapy Herceptin and is indicated for treating HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Clinical Development Success
The partnership comes as the European Medicines Agency (EMA) reviews Tuznue's marketing authorization application, supported by robust clinical data from two pivotal studies. At the American Society of Clinical Oncology's annual meeting earlier this year, Prestige presented compelling evidence demonstrating the biosimilar's equivalent safety, pharmacokinetics, efficacy, immunogenicity, and tolerability compared to the reference product.
The TROIKA-I study enrolled 101 healthy volunteers who were randomized to receive either Tuznue or EU or US Herceptin formulations. Each participant received a single 6 mg/kg intravenous dose administered over 90 minutes. Results confirmed that the biosimilar was safe and well-tolerated with pharmacokinetic profiles comparable to Herceptin.
Phase 3 Efficacy Data
The larger TROIKA study, a randomized, double-blind, multicenter phase 3 trial, evaluated 574 patients for response across multiple endpoints. Patients received either Tuznue or EU-Herceptin in combination with chemotherapy during neoadjuvant treatment, followed by trastuzumab monotherapy in the adjuvant phase.
The trial met its primary endpoint, demonstrating statistical equivalence between the biosimilar and reference product. Complete pathological response rates were 46.6% in the Tuznue arm versus 46.2% in the Herceptin arm. Breast pathological complete response rates reached 55.0% for Tuznue compared to 53.4% for Herceptin, while overall response rates were 90.8% and 89.4%, respectively.
Pharmacokinetic trough levels met predefined equivalency margins, and the safety profile showed similar adverse event patterns between the biosimilar and reference product, further supporting the biosimilar's therapeutic equivalence.
Commercial Strategy and Manufacturing
Under the partnership terms, Teva Israel will handle local regulatory registration, sales, and marketing activities within Israel. Prestige Biopharma retains responsibility for EMA regulatory registration and will supply Tuznue from its manufacturing facilities in Osong, Republic of Korea, to Teva Israel's operations in Petah Tikva, Israel.
This agreement represents the third major commercialization partnership for Tuznue, following deals with Pharmapark LLC for the Russian market and Mundipharma for commercialization across France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland, and Austria.
Broader Pipeline Development
Beyond Tuznue, Prestige Biopharma is advancing an extensive biosimilar portfolio targeting major oncology and immunology therapeutics. The company's pipeline includes biosimilar candidates referencing bevacizumab (Avastin), adalimumab (Humira), denosumab (Prolia), aflibercept (Eylea), pertuzumab (Perjeta), eculizumab (Soliris), and ipilimumab (Yervoy).
The trastuzumab biosimilar market represents a significant opportunity as healthcare systems seek cost-effective alternatives to expensive biologics while maintaining therapeutic efficacy for cancer patients. With multiple regulatory submissions underway and expanding commercial partnerships, Prestige is positioning itself as a key player in the global biosimilar landscape.
