Prestige BioPharma's Tuznue Receives European Commission Approval as Herceptin Biosimilar
Key Insights
Prestige BioPharma (search)'s Tuznue (trastuzumab) has been granted final approval by the European Commission as a biosimilar to Herceptin, a drug used to treat breast and metastatic gastric cancers.
Tuznue is the third trastuzumab biosimilar approved in Europe, positioning Prestige BioPharma (search) to compete in a market valued at approximately $4.1 billion annually.
The company plans to leverage Tuznue's approval to accelerate marketing authorization for its Avastin biosimilar, HD204 (bevacizumab), currently undergoing Phase 3 trial analysis.
Prestige BioPharma (search), a biopharmaceutical company based in Singapore, has secured final approval from the European Commission (EC) for Tuznue, a biosimilar of Herceptin (trastuzumab). This approval positions Tuznue as a treatment option for breast cancer (search) and metastatic gastric cancer (search) within the European market, estimated at $4.1 billion annually. The decision follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July.
Tuznue joins Celltrion's Herzuma and Samsung Bioepis' Samfenet as the third trastuzumab biosimilar approved in Europe. Prestige BioPharma (search) aims to capitalize on this approval to expedite the marketing authorization of its Avastin biosimilar, HD204 (bevacizumab), which is currently in Phase 3 trials.
Market Strategy and Expansion
Following the EC's approval, Prestige BioPharma (search) will receive marketing authorization milestones from global pharmaceutical companies with existing licensing agreements. This marks the first milestone achievement from the company's pipeline since its inception. Revenue generation is anticipated to commence upon the initiation of sales and order placements. The company intends to collaborate with major global pharmaceutical companies as distributors in Europe to facilitate rapid market entry.
Park So-yeon, CEO of Prestige BioPharma (search), is scheduled to attend CPHI Milan 2024, a global pharmaceutical exhibition, to meet with potential partners. "We expect to achieve price competitiveness through our full value chain and the sales strength of our global partners, allowing us to capture market share as soon as Tuznue is officially launched," Park stated.
Future Pipeline Development
Prestige BioPharma (search) plans to rapidly advance its pipeline of 15 follow-up biosimilars, leveraging the expertise gained from Tuznue’s approval in Europe. This strategic move underscores the company's commitment to expanding its portfolio of biosimilar products.