Teva and Prestige Biopharma Enter License Agreement for Tuznue® Commercialization in Europe
Rhea-AI Summary
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.
Positive
- 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
Negative
- None.
News Market Reaction
On the day this news was published, TEVA declined 2.21%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- 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.
Teva Media Inquiries
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries
TevaIR@tevapharm.com
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?
