Teva and Prestige Biopharma Enter License Agreement for Tuznue® Commercialization in Europe
Teva (NYSE: TEVA) entered a license and supply agreement with Prestige Biopharma to commercialize Tuznue® (trastuzumab), a biosimilar to Herceptin®, across a majority of European markets.
Tuznue® is approved for breast cancer and metastatic gastric cancer and received European Commission marketing authorization in September 2024. Under the deal, Prestige will produce and supply Tuznue® from its EU‑GMP, single‑use facilities while Teva will market and distribute using its European biosimilars commercial network.
Teva (NYSE: TEVA) ha stipulato un accordo di licenza e fornitura con Prestige Biopharma per commercializzare Tuznue® (trastuzumab), un biosimilare di Herceptin®, nella maggior parte dei mercati europei.
Tuznue® è approvato per il cancro al seno e per il cancro gastrico metastatico e ha ottenuto l'autorizzazione all'immissione in commercio della Commissione europea nel settembre 2024. Nell'ambito dell'accordo, Prestige produrrà e fornirà Tuznue® dai propri impianti EU‑GMP, a uso singolo, mentre Teva commercializzerà e distribuirà utilizzando la sua rete commerciale di biosimilari europea.
Teva (NYSE: TEVA) solicitó un acuerdo de licencia y suministro con Prestige Biopharma para comercializar Tuznue® (trastuzumab), un biosimilar de Herceptin®, en la mayor parte de los mercados europeos.
Tuznue® está aprobado para cáncer de mama y cáncer gástrico metastásico y recibió la autorización de comercialización de la Comisión Europea en septiembre de 2024. Bajo el acuerdo, Prestige producirá y suministrará Tuznue® desde sus instalaciones EU‑GMP, de un solo uso, mientras que Teva comercializará y distribuirá utilizando su red comercial europea de biosimilares.
테바(NYSE: TEVA)는 Prestige Biopharma와 라이선스 및 공급 계약을 체결하여 Tuznue® (trastuzumab), Herceptin®의 바이오시밀러를 유럽의 대다수 시장에서 상용화할 예정입니다.
Tuznue®는 유방암 및 전이성 위암에 대해 승인되었으며 2024년 9월에 유럽 위원회 마케팅 승인을 받았습니다. 이 거래에 따라 Prestige는 EU‑GMP, 단일사용 시설에서 Tuznue®를 생산하고 공급하는 반면, Teva는 유럽 바이오시밀러 상업 네트워크를 사용하여 마케팅 및 유통할 것입니다.
Teva (NYSE: TEVA) a conclu un accord de licence et de fourniture avec Prestige Biopharma pour commercialiser Tuznue® (trastuzumab), un biosimilaire d'Herceptin®, dans la majorité des marchés européens.
Tuznue® est approuvé pour le cancer du sein et le cancer gastrique métastatique et a obtenu l'autorisation de mise sur le marché par la Commission européenne en septembre 2024. Dans le cadre de l'accord, Prestige produira et approvisionnera Tuznue® à partir de ses installations EU‑GMP, à usage unique, tandis que Teva commercialisera et distribuera en utilisant son réseau commercial européen de biosimilaires.
Teva (NYSE: TEVA) hat mit Prestige Biopharma eine Lizenz- und Liefervereinbarung getroffen, um Tuznue® (Trastuzumab), ein Biosimilar zu Herceptin®, in der Mehrzahl europäischer Märkte zu vermarkten.
Tuznue® ist für Brustkrebs und metastasierenden Magenkrebs zugelassen und erhielt die Marketinggenehmigung der Europäischen Kommission im September 2024. Im Rahmen des Abkommens wird Prestige Tuznue® aus seinen EU‑GMP, Einweg-Anlagen produzieren und liefern, während Teva es vermarkten und über sein europäisches Biosimilars-Vertriebsnetz vertreiben wird.
تيفا (NYSE: TEVA) وقعت اتفاقية ترخيص وتوريد مع Prestige Biopharma لتسويق Tuznue® (trastuzumab)، وهو دواء بيوسميلر من Herceptin®، في غالبية الأسواق الأوروبية.
Tuznue® مُعتمد لعلاج سرطان الثدي وسرطان المعدة المتقدم وتلقى تصريح التسويق من المفوضية الأوروبية في سبتمبر 2024. وبموجب الصفقة، ستقوم Prestige بإنتاج وتوريد Tuznue® من مرافقها EU‑GMP، ذات الاستخدام الواحد، بينما Teva ستقوم بالتسويق والتوزيع باستخدام شبكة التسويق الحيوي النظيرية الأوروبية الخاصة بها.
Teva (NYSE: TEVA) 与 Prestige Biopharma 签署了许可和供应协议，在大部分欧洲市场商业化 Tuznue® (trastuzumab)，这是 Herceptin® 的生物类似药。
Tuznue® 已获批用于乳腺癌和转移性胃癌，且获得 欧洲委员会在 2024 年 9 月的上市许可。根据协议，Prestige 将在其 EU‑GMP、一次性使用 设施中生产并供应 Tuznue®，而 Teva 将利用其欧洲生物仿制药商业网络进行市场营销和分销。
- License grants Teva rights to market Tuznue® in a majority of Europe
- Tuznue® holds EC marketing authorization (September 2024)
- Prestige to supply from EU‑GMP certified, single‑use production facilities
- Teva provides established European biosimilars commercial network
- None.
Insights
Teva gains European commercialization rights for Tuznue®, creating near-term revenue opportunity via established biosimilar channels.
Teva will market and distribute Tuznue® across a majority of European markets while Prestige Biopharma remains responsible for production and supply from its EU-GMP facilities. This arrangement separates commercialization from manufacturing risk and leverages Teva’s existing commercial infrastructure to accelerate patient access following the EC approval in
The commercial outcome depends on sustained supply performance and payer acceptance of the biosimilar; manufacturing continuity from Prestige’s high‑tech single‑use lines and timely deliveries are critical. Pricing, reimbursement, and national tender outcomes — not disclosed here — will determine margin and uptake, so execution risk is operational and market access rather than regulatory.
Watch for initial roll‑out metrics and market launches in the coming quarters after
- Teva and Prestige announce a license and supply agreement for the commercialization of Prestige’s Tuznue®, a biosimilar to Herceptin® (trastuzumab)
- Tuznue® received European Commission (EC) marketing authorization in September 2024
- Partnership brings together both companies’ expertise in biosimilars
TEL AVIV, Israel, Oct. 20, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) entered into a license agreement with Prestige Biopharma, for the commercialization of Tuznue® (trastuzumab), a biosimilar to Herceptin®, across a majority of European markets.
Tuznue® is approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received the European Commission (EC) marketing authorization for Tuznue® in September 2024.
Under the terms of the license and supply agreement, Teva secured rights to market and distribute Tuznue® in a majority of European markets, leveraging its extensive commercial network and proven expertise in biosimilars. Prestige Biopharma will be responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology.
“We are passionate about the future of biosimilars and the value they bring to patients and healthcare systems,” said Richard Daniell, Executive Vice President, European Commercial, Teva. “Our deep commercial experience in biosimilars and broad sales and marketing reach across Europe enables us to bring critical medicines to patients. We are looking forward to working together with Prestige to make Tuznue® a commercial success in Europe.”
"We are excited to collaborate with Teva, a global biopharmaceutical leader, to bring Tuznue® to patients across Europe," said Lisa Park, CEO of Prestige Biopharma. "This collaboration is a significant step in establishing Prestige Biopharma as a global biopharmaceutical leader. Teva’s extensive market reach will drive the successful launch of Tuznue® while accelerating the development of our broader biosimilar pipeline, including bevacizumab and 14 additional candidates." The approval marks a major milestone for Prestige’s biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across Europe.
About Tuznue®
Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It shows similar efficacy and safety to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic gastric cancer.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
About Prestige Biopharma
Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio and a dedicated GMP manufacturing facility in Korea with a capacity of 154,000 liters. Among its many assets, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development.
Teva Cautionary Note Regarding Forward-Looking Statements
This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to effectively execute our agreement with Prestige Biopharma for the commercialization of Tuznue® (trastuzumab), the biosimilar to Herceptin® in a majority of European markets; our marketing and distribution capabilities in the European market; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to profitably commercialize our biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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FAQ
What rights did Teva secure under the Tuznue® license agreement with Prestige (TEVA)?
When did Tuznue® receive European Commission approval and for which indications?
Who will manufacture and supply Tuznue® for Teva in Europe?
How will Teva support the Tuznue® launch in Europe (TEVA)?
Does the agreement include Prestige’s broader biosimilar pipeline details?
What is the expected patient impact of the Tuznue® commercialization in Europe?
