Eculizumab-AAGH

Already sharing the load on two biosimilar assets, Teva Pharmaceutical and Samsung Bioepis have elected to take their partnership to the next level. This week, the companies unveiled an expanded deal to develop and commercialize up to six potential biosimilar candidates—copycats of off-patent biologic drugs that fill the same niche as small-molecule generics—including two that will reference AstraZeneca’s immunology stalwart Fasenra and Novartis’ Ilaris, cleared in periodic fever syndromes and Still’s disease, among other indications. The pact will see Samsung Bioepis take charge of development, regulatory work and manufacturing, while Teva is on deck for commercialization duties around the world—including the U.S., Europe and Canada—if the biosimilars pass muster with regulators, the companies said in a release. The companies added that they’ve “agreed to an option for expanding the partnership to other territories,” too. Teva, already well known for its generics and biosimilar bona fides, linked up with South Korea’s Samsung Bioepis last January in a similar agreement focused on Epysqli, a biosimilar developed by Samsung that references AZ’s Soliris in the U.S. Subsequently, the partners over the summer struck up a licensing and commercialization accord for the Eylea biosimilar Opuviz in Canada. Teva and Samsung Bioepis cited their previous tie-ups as motivation for the latest deal, homing in specifically on the success of their work on Epysqli in the U.S. “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company,” said Richard Francis, Teva’s CEO, in a statement. “This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the U.S.” The partners did not divulge details around the other biosimilar targets. Financial details of the pact were not disclosed either. The companies’ refreshed agreement follows a string of other high-ambition biosimilar announcements in 2026, as specialists in the field have looked to capitalize on a massive approaching patent cliff for many of the industry’s lucrative branded drugs. That reality goes part and parcel with the concept of the ‘biosimilar void,’ which refers to a dearth of in-development biologic copycats for many drugs facing exclusivity losses in the late 2020s and early 2030s. In turn, that development gap both poses threats to access to more affordable biosimilars, plus tremendous opportunities for companies that can seize on the open playing field. Samsung Bioepis, for its part, lined up an agreement with another of the industry’s big players, Sandoz, back in March, to partner on up to five biosimilars. The first asset on the docket for that deal is SB36, which references Takeda’s Entyvio and is in development by Samsung. Meanwhile, Sandoz itself set an ambitious goal early last month to establish a portfolio of more than 100 biosimilars by 2040, up from the 13 it currently markets. At an investor event in September, Sandoz leadership pointed to that same wave of heavy patent losses approaching, noting that a “golden decade” for its own business could exist on the other side of that cliff.

The agreement covers SB41, a potential biosimilar candidate referencing Fasenra ® (benralizumab), and SB44, a potential biosimilar candidate referencing Ilaris ® (canakinumab) with an option for 4 additional assets The partnership will cover development and commercialization in the United States, Europe, and Canada, with an option to expand to other territories The partnership brings together Samsung Bioepis’ development, regulatory and manufacturing capabilities with Teva’s global commercial reach to advance the investigational biosimilar candidates and help bring additional important treatment options to patients worldwide INCHEON, Korea & TEL AVIV, Israel--(BUSINESS WIRE)-- #Fasenra --Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra ®1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris ®2 (canakinumab). Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, and manufacture of the biosimilars, while Teva will be responsible for commercialization in global markets, including the United States (U.S.), Europe, and Canada. The companies have agreed to an option for expanding the partnership to other territories. This agreement reinforces the long-standing and successful partnership between Samsung Bioepis and Teva, which has already resulted in the successful commercialization of EPYSQLI ® (eculizumab-aagh) in the U.S. The companies have also expanded that agreement further to include OPUVIZ ® (aflibercept) in Canada. The expanded collaboration reflects a shared approach to combining complementary capabilities for broadening access to biosimilar medicines across global markets. “We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.” Richard Francis, President and CEO of Teva said, “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the U.S. By combining a strong and growing portfolio and our excellent global commercial capabilities, we are strengthening our leadership position in biosimilars and our ability to bring more treatment options to patients around the world.” About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into 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 . 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,” “may,” “project,” “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 successfully execute the license, development and commercialization agreement with Samsung Bioepis; 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 expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ending December 31, 2025, including in the section captioned “Risk Factors” and “Cautionary Note Regarding 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. 1 Fasenra is a trademark of AstraZeneca AB. 2 Ilaris is a trademark of Novartis AG. Contacts MEDIA CONTACT Samsung Bioepis Media Inquiries: Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquiries: TevaIR@Tevapharm.com