Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market

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Teva Pharmaceuticals, a United States-based affiliate of Teva Pharmaceutical Industries, and Samsung Bioepis launched eculizumab-aagh (under the brand name EPYSQLI), a biosimilar referencing eculizumab (brand name Soliris), in the US in April 2025. Eculizumab-aagh was approved by FDA in July 2024 to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), and in November 2024 to treat generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive, all difficult-to-treat rare diseases, according to a company press release (1).

The biosimilar is being offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference biologic. Teva and Samsung Bioepis entered into a strategic partnership in January 2025 to commercialize eculizumab-aagh in the US (2).

“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, US Biosimilars, Teva, in the company’s April 7, 2025 press release (1). “We are proud to launch EPYSQLI in the US 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.”

PNH, aHUS, and gMG are life-threatening diseases that, if left untreated, can lead to kidney disease, kidney failure, or respiratory failure. Because of this, it is important for patients to have early access to treatment, according to the release.

“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 US, we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, executive vice-president and head of Global Commercial Division, Samsung Bioepis, in the release. “Our mission is to positively impact and ensure the sustainability of healthcare 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 US.”

The reference biologic, eculizumab, is a monoclonal antibody and anti-C5 complement inhibitor that is well-established as a standard-of-care treatment for PNH and aHUS, which have an estimated US prevalence of approximately 50,000 and 5000 patients, respectively (3,4). Teva noted in its release that approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, and, furthermore, two-thirds of patients discontinue using eculizumab within an average of 1.5 years. This outcome can be attributed to several factors, including the high cost of treatment (5).

Biosimilars such as eculizumab-aagh can increase the affordability and accessibility associated with these therapies.

Under the January 2025 agreement between Teva and Samsung Bioepis, Samsung Bioepis is responsible for development, manufacturing, and supply of eculizumab-aagh, and Teva is responsible for the commercialization of the product in the US through its experience and sales and marketing infrastructure.

References

1. Teva Pharmaceutical Industries. Teva and Samsung Bioepis Announce Biosimilar EPYSQLI (eculizumab-aagh) Injection Now Available in the United States. Press Release. April 7, 2025.
2. Teva Pharmaceutical Industries. Teva and Samsung Bioepis Enter into a Strategic Partnership for Commercialization of EPYSQLI (eculizumab-aagh) in the United States. Press Release. Jan. 10, 2025
3. National Center for Advancing Translational Sciences. Paroxysmal Nocturnal Hemoglobinuria. rarediseases.info.nih.gov (accessed April 10, 2025).
4. National Center for Advancing Translational Sciences. Atypical Hemolytic Uremic Syndrome. rarediseases.info.nih.gov (accessed April 10, 2025).
5. Cheng, W. Y.; Sarda, S. P.; Mody-Patel, N.; et al. Real-World Healthcare Resource Utilization (HRU) and Costs of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Receiving Eculizumab in a US Population. Adv. Ther. 2021, 38 (8), 4461–4479. DOI: 10.1007/s12325-021-01825-4.