Benralizumab

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

Amgen and AstraZeneca’s inflammatory disease drug Tezspire has clinched a phase 3 win in eosinophilic esophagitis (EoE) as the partners eye another challenge to Sanofi and Regeneron’s incumbent Dupixent. A phase 3 EoE trial for Tezspire has hit all primary and key secondary endpoints, Amgen and AZ announced Thursday. By targeting an upstream driver of inflammation, Tezspire demonstrated statistically significant improvements in both histologic remission—defined by a low count of peak eosinophils in the esophagus—and swallowing difficulties compared to placebo at week 24, according to the companies. For both Tezspire doses tested, the treatment effects on the study’s co-primary endpoints lasted through week 52, the companies added. The success from the phase 3 Crossing trial positions the anti-TSLP biologic to potentially expand into its third inflammatory disease indication beyond severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Amgen and AZ said they will share the study’s results with regulatory authorities and with the scientific community at an upcoming medical meeting. If approved, Tezspire would open a new front in its rivalry with Dupixent, which became the first medicine specifically indicated for EoE in 2022. Compared with Tezspire’s upstream targeting of TSLP, Dupixent works downstream in the immune cascade by blocking IL-4 and IL-13 signaling pathways. EoE is a chronic inflammatory disease of the esophagus, which can lead to esophageal narrowing and difficulty swallowing, known as dysphagia. The disorder is estimated to affect more than 470,000 people in the U.S., with increased prevalence in the past few years, according to Amgen and AZ. Before biologics are introduced, first-line treatment of EoE typically centers on three methods, frequently referred to as the “3Ds”—drugs, diet and dilation. For drugs, proton pump inhibitors such as omeprazole and swallowed topical corticosteroids like fluticasone are common options. During the Crossing trial, patients were allowed to remain on those background medications. “Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food, and emotional and daily-life impacts of the disease,” Arjan Bredenoord, M.D., a gastroenterologist at the Amsterdam University Medical Center in the Netherlands and primary investigator of the Crossing trial, said in an Aug. 27 statement. “The impressive results from the Crossing trial sustained over 52 weeks demonstrate that [Tezspire], taken every four weeks, could provide a new approach to treating this disease, with the potential to help more patients achieve remission and symptom improvement,” he added. In addition to the primary endpoints measured at week 24 and the key secondary endpoints evaluated at week 52, Crossing also hit other goals, including endoscopic disease features and histologic severity and extent at weeks 24 and 52, plus endoscopic response, inflammatory remission and total endoscopic remission at week 52. Tezspire’s trial win now gives AZ another shot at EoE after its anti-IL5 antibody Fasenra failed to make the cut. Back in 2022, the British pharma reported mixed results from the phase 3 Messina trial, in which Fasenra achieved better histological disease remission compared to placebo but came up short on the dysphagia symptoms metric. Besides EoE, Tezspire is undergoing phase 3 development—the Journey and Embark trials—in chronic obstructive pulmonary disease (COPD). First approved by the FDA for severe asthma in late 2021, Tezspire generated $1.9 billion in combined sales for Amgen and AZ in 2025, up from nearly $1.3 billion the year before. With a much broader label beyond inflammatory conditions affecting the airway, Dupixent brought in $17.8 billion in 2025 global sales. Meanwhile, against the backdrop of Tezspire’s first-in-class wins, drugmakers are developing more anti-TSLP agents. GSK recently launched phase 3 tests of its twice-yearly candidate felcorekibart (GSK5784283) for COPD and asthma after buying the long-acting drug in 2024. Last year, Roche licensed a TSLPxIL-33 bispecific antibody from China’s Qyuns Therapeutics in a deal potentially worth more than $1 billion. Qyuns also out-licensed a TSLPxIL-13 bispecific candidate to Windward Bio, which secured $165 million in crossover financing in May to help advance a twice-yearly anti-TSLP candidate into phase 3. Sanofi is also developing a TSLPxIL-13 bispecific nanobody called lunsekimig, which recently hit goals in a pair of midstage studies for asthma and CRSwNP.