Teva has signed a license and supply agreement with Prestige Biopharma to commercialize Tuznue, a biosimilar to Herceptin (trastuzumab), across a majority of European markets. The product, which received European Commission marketing authorization in September 2024, is indicated for HER2-positive early and metastatic breast cancer and HER2-positive metastatic gastric cancer. Under the deal, Teva will lead marketing and distribution through its pan-European network, while Prestige will manufacture and supply from EU-GMP facilities.
The move underscores Teva’s intent to deepen its hospital biosimilars franchise in Europe, where tender-driven markets reward scale, reliability, and price discipline. It also raises a strategic question: in a class flooded with trastuzumab biosimilars, can a late entrant carve share as clinical practice shifts toward subcutaneous combination dosing and earlier use of antibody–drug conjugates?
Timing matters. European payers are under intensifying budget pressure and oncology tenders are coming up for renewal in several large markets. Another qualified supplier increases competition and could further compress net prices in a molecule that remains foundational for many HER2 regimens despite evolving treatment paradigms. For patients, added supply security and lower acquisition costs can reduce delays and broaden access, particularly in regions where formulary decisions are centralized. For hospital pharmacists and procurement bodies, Teva’s footprint and logistics capabilities may offer risk mitigation through multi-market continuity of supply, an increasingly critical differentiator after recent shortages in other biologic classes.
The commercial challenge is real. Trastuzumab is one of Europe’s most mature biosimilar categories, with established players from Amgen, Pfizer, Samsung Bioepis, Celltrion, Accord, and others. Differentiation will depend less on clinical messaging—therapeutic equivalence is well accepted—and more on aggressive tender pricing, dependable manufacturing, and value-added services such as infusion coordination, nurse education, and pharmacovigilance support. Teva’s history in oncology biosimilars and generics gives it credibility on these operational levers, but margin resilience will be tested as price floors approach sustainability limits for smaller manufacturers.
For Medical Affairs, the priority will be pragmatic switching guidance and post-launch evidence that smooths hospital adoption. While automatic substitution for biologics is uncommon in Europe, therapeutic interchange at the institution level is routine in tenders. Clear protocols for mid-cycle switching, handling of subcutaneous versus intravenous transitions, and nocebo minimization will matter to oncologists and infusion teams. RWE on immunogenicity and persistence across lines of therapy, including metastatic gastric cancer where patient numbers are smaller and variability is higher, can bolster confidence and justify procurement decisions beyond list price.
Strategically, the partnership fits a broader pattern: Asian manufacturers with scalable, single-use biomanufacturing are pairing with Western commercial engines to accelerate European biosimilar penetration. For Prestige, out-licensing de-risks commercialization and could create a runway to finance its bevacizumab and broader pipeline. For Teva, it adds another oncology anchor that can be bundled in multi-asset tenders as the company pursues a growth pivot built on specialty and biosimilars, complementing separate alliances in immunology and ophthalmology.
The open question is how long the intravenous trastuzumab market will sustain competitive oxygen as subcutaneous fixed-dose combinations and next-generation HER2 therapies move earlier in care. If Teva can leverage scale to win tenders now and expand the collaboration into adjacent oncology biologics, it could turn a crowded class into a platform play. If not, the lesson for late entrants may be stark: in mature biosimilars, distribution muscle and supply reliability are necessary but no longer sufficient without portfolio breadth and bundling power.
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.
