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PARSIPPANY, NJ, USA and INCHEON, Korea I April 07, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI ® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris ® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. EPYSQLI will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris ® , offering one of the greatest cost-saving biosimilars to Soliris ® in the U.S. “Individuals living with rare diseases, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis, often have limited access to life-enhancing medicines,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “We are proud to launch EPYSQLI in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities.” “Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment. The availability of EPYSQLI means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product. Based on our robust track record supplying biosimilars in the U.S., we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, Executive Vice President and Head of Global Commercial Division of Samsung Bioepis. “Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines. We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.,” she added. The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively. 1,2 Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, and two-thirds of patients discontinue eculizumab within an average of 1.5 years, which can be attributed to several factors including the high treatment cost. 3 Biosimilars, like EPYSQLI, are highly similar to their reference product with no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies. Biosimilars are approved according to the same standards of pharmaceutical quality that apply to all biological medicines, with comparable safety and efficacy to the reference product expected. 4 The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients. 5 In July 2024, EPYSQLI was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris ® for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody positive. The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris ® , following the expiration of exclusivity for the first interchangeable biosimilar. In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of EPYSQLI in the U.S. market. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing and supply, while Teva is responsible for the commercialization of the product in the U.S., leveraging its experience and extensive sales and marketing infrastructure. About EPYSQLI ® (eculizumab-aagh) injection, for intravenous use EPYSQLI is a complement inhibitor indicated for the treatment of patients with: Limitation of Use: EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Please click here for full Prescribing Information for EPYSQLI, including BOXED WARNINGS. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com . About Samsung Bioepis 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. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . References SOURCE: Samsung Bioepis

The end of the U.S. patent runway is nearing for 10 industry blockbusters in 2025. While each year features high-profile losses of exclusivity in the pharma industry, this year's list is something of a doozy.For one, Johnson & Johnson's Stelara is already facing off against several biosimilars, and several more are yet to come as the year plays out. With $6.72 billion in U.S. sales in 2024, the drug is the largest U.S. loss of exclusivity since AbbVie's megablockbuster Humira tumbled over the patent cliff in early 2023. Johnson & Johnson had previously warned of a "late 2023" patent cliff for Stelara, but the company was able to squeeze more life out of its key immunology moneymaker through a series of legal settlements.Johnson & Johnson's not alone in losing U.S. market exclusivity on a key sales driver this year. Also facing ongoing or future declines for their top revenue generators are Regeneron with eye drug Eylea, Amgen with bone medicines Prolia/Xgeva and Novartis with heart failure therapy Entresto. Eylea already faces its first U.S. biosimilar after Amgen launched Pavblu in November. Fierce Pharma chose to include Eylea in this report—despite the biosimilar launch happening last year—because the commercial situation is still playing out for Regeneron and to not exclude a key development in an important market.Amgen, for its part, collected $4.39 billion in revenue from its key bone medicines Prolia and Xgeva last year. While the company has built its own impressive biosimilar business over the years, it'll have to play an unfamiliar role and watch copycat drugs eat away at the market for its originators starting in late May and early June.Novartis, meanwhile, has warned of a "mid-2025" loss of U.S. exclusivity for Entresto as a key combination patent nears its expiration this summer. Besides Entresto, Novartis has two other big-selling products on this list in Promacta and Tasigna.Moving down the list, readers will likely notice two high-profile drugs from AstraZeneca. Rare disease medicine Soliris, picked up in AZ's buyout of Alexion, is set to face its first biosimilar from Amgen sometime in the second quarter. And Brilinta, a cardiometabolic drug once pegged to be a key blockbuster but that never quite met expectations, is also running out of its U.S. patent protections in the near future.For one measure of the high-profile nature of the drugs on this list, look no further than last year's version of the report. With $1.45 billion in prior-year U.S. sales, Bristol Myers Squibb's Sprycel led the 2024 group. But, if compared against the 2025 class of patent expirations, Sprycel would rank No. 6. There are always uncertainties in compiling this report due to the unpredictable nature of patent litigation and regulatory interactions. This year, the drug with the most apparent uncertainty is J&J's Simponi and Simponi ARIA. That medicine's inclusion hinges on a potential fourth-quarter approval—and launch—of Teva and Alvotech's AVT05. We opted to include the medicine because a key patent has already expired, and a reputable biosimilar team is marching through the regulatory process.To compile this report, Fierce Pharma parsed company filings, presentations and conference call transcripts. We also used published research from pharmacy benefit manager OptumRx and healthcare services firm Cardinal Health. The report ranks the top U.S. losses of exclusivity based on U.S. sales from the prior year.