Eculizumab

‌4月7日‌，Teva对外宣布，EPYSQLI®（eculizumab-aagh）已在美国上市。EPYSQLI是Soliris®（eculizumab）的生物类似药，用于治疗阵发性睡眠性血红蛋白尿症（PNH）、非典型溶血性尿毒症综合征（aHUS）和成人抗乙酰胆碱受体（AchR）抗体阳性的重症肌无力（gMG）患者。EPYSQLI将以参考产品Soliris®批发采购价（WAC）的30%折扣价提供，成为美国市场上相对于Soliris®而言最具成本节约效益的生物类似药之一。“患有罕见疾病（包括阵发性睡眠性血红蛋白尿症、非典型溶血性尿毒症综合征和重症肌无力）的患者往往难以获得能够改善生活质量的药物，”Teva美国生物类似药业务高级副总裁Thomas Rainey表示。“我们很自豪能在美国推出EPYSQLI，作为一种新的、更实惠的治疗方案，以帮助扩大这些服务不足人群的用药范围，并进一步扩展我们的生物类似药产品组合，通过利用我们经过验证的商业化能力建立战略伙伴关系，将重要药物带给患者。”“如果不进行治疗，PNH、aHUS和gMG等危及生命的疾病可能导致肾病、肾衰竭或呼吸衰竭，因此患者尽早获得治疗至关重要。EPYSQLI的上市意味着患者现在能够以更低的成本获得另一种治疗方案，且该方案的质量、安全性和有效性已经得到证明，与参考产品相当。基于我们在美国供应生物类似药的良好业绩，我们完全有能力将这种改变生活的药物带给患者，”Samsung Bioepis全球商业部执行副总裁兼负责人Linda MacDonald表示。“我们的使命是通过提供负担得起、质量有保障、安全有效的生物药物，对医疗保健系统的可持续性产生积极影响并确保其可持续性。我们将与Teva紧密合作，确保这种药物能够被美国的支付方、医疗专业人士和患者所获取，”她补充道。单克隆抗体和抗C5补体抑制剂eculizumab是治疗PNH和aHUS的标准疗法，这两种罕见病在美国的患病率分别约为50,000人和5,000人。1,2 大约70%接受eculizumab治疗的PNH患者未按标签规定的剂量用药，三分之二的患者在平均1.5年内停止使用eculizumab，这可归因于多种因素，包括高昂的治疗费用。3 生物类似药（如EPYSQLI）与其参考药物高度相似，在安全性、纯度和效力方面没有临床意义上的差异，并且可以提高这些疗法的可负担性和可及性。生物类似药按照与所有生物药物相同的药品质量标准获得批准，预期具有与参考药物相当的安全性和有效性。4 生物类似药的推出提高了药物分子的利用率，因为较低的成本为患者提供了更多的用药机会。2024年7月，EPYSQLI获得美国食品药品监督管理局（FDA）批准，作为Soliris®的生物类似药，用于治疗PNH患者以减少溶血，以及治疗aHUS以抑制补体介导的血栓性微血管病。2024年11月，其适应症扩大至包括治疗成人抗AchR抗体阳性的重症肌无力。FDA已初步认定，在首个可互换生物类似药的独占期届满后，EPYSQLI将与参考生物药Soliris®互换。2025年1月，Teva和Samsung Bioepis达成战略合作，共同推广EPYSQLI在美国市场的上市。根据协议条款，Samsung Bioepis负责开发、制造和供应，而Teva则负责利用自身经验和庞大的销售和营销基础设施在美国推广该产品。药事纵横投稿须知：稿费已上调，欢迎投稿

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