Teva has signed a licensing and supply agreement with Prestige Biopharma to commercialize Tuznue, a biosimilar of Herceptin (trastuzumab), across most European markets. The product, approved by the European Commission in September 2024, is indicated for HER2-positive early and metastatic breast cancer as well as metastatic gastric cancer. Under the deal, Teva will handle commercialization and distribution through its established European footprint, while Prestige will manufacture and supply the product from its EU-GMP-certified facilities.
The strategic question is whether a late entrant can still create value in one of Europe’s most mature oncology biosimilar classes. Trastuzumab has been contested for years by multiple biosimilar players, compressing prices and narrowing room for differentiation. Teva’s bet is that scale, tender expertise, and supply reliability can still win share. For Prestige, the path to impact runs through operational excellence and a partner that can execute across fragmented procurement environments. If the duo can pair aggressive pricing with service and supply continuity, this move could reset tiers in hospital tenders that have grown increasingly transactional.
Why it matters now is straightforward: oncology budgets remain under pressure, and hospital tenders for monoclonal antibodies continue to be a primary lever for payers. Further price competition in trastuzumab can free resources amid expanding therapeutic spend in other categories, including GLP-1s and novel oncology agents. For patients, additional competitive pressure can translate into broader access and reduced delays in therapy initiation, particularly in markets where hospital formulary rotations still drive availability. For HCPs, switching protocols are well-established in HER2 disease, but new entrants must still underwrite confidence with real-world evidence, pharmacovigilance, and operational support to minimize disruptions in infusion centers.
The commercial challenge is not just price. Europe’s procurement is evolving from single-molecule events to multi-asset oncology portfolios where service, delivery dependability, and inventory management can tip decisions. Teva’s multi-country distribution infrastructure is designed for these dynamics and could position Tuznue within bundled bids alongside other oncology products. Prestige’s manufacturing approach—EU-GMP and single-use bioprocessing at scale—aims to mitigate supply risk, a key tender criterion after years of pandemic-era and geopolitical disruptions. Reliability has become a competitive attribute on par with discount depth.
This deal also underscores an industry pattern: capital-light licensing that pairs Asian manufacturing scale with Western commercialization engines. As the cost of development and analytical characterization rises, regional specialization is becoming a feature of the biosimilar market. The model can accelerate time-to-revenue for developers while enabling large distributors to refresh portfolios without bearing upstream development risk. It also sets the stage for pipeline expansion; Prestige’s mention of bevacizumab and additional candidates signals potential for a broader oncology basket deal if Tuznue executes.
The competitive backdrop is unforgiving. Incumbent trastuzumab biosimilars have entrenched positions and long-standing contracts. Roche’s residual share is concentrated in segments where subcutaneous convenience and workflow benefits still command attention, though tender-driven IV usage remains dominant in many systems. Teva will need to calibrate country-by-country—leaning on price and supply in highly commoditized tenders, and on medical engagement and pragmatic implementation support in markets where clinician preference still shapes uptake.
If Tuznue gains traction, expect follow-on moves: portfolio bundling across tumor types, deeper RWE programs to support switching stability, and potentially expanded licensing between Teva and Prestige. The sharper question for competitors is whether service-led differentiation will matter enough to avoid pure race-to-the-bottom pricing, and for payers, whether another capable supplier can catalyze a new round of savings in HER2 oncology without straining supply resilience.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
