Teva and Samsung Bioepis Launch Biosimilar Epysqli

Teva Pharmaceuticals and Samsung Bioepis have announced the US launch of Epysqli (eculizumab-aagh), a biosimilar to the blockbuster biologic Soliris (eculizumab), following FDA approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in anti–acetylcholine receptor (AchR) antibody–positive adult patients.^1,2

PNH and aHUS are ultrarare diseases with estimated US prevalence rates of approximately 50,000 and 5000, respectively. | Image credit: olegganko - stock.adobe.com

Epysqli will be available at a 30% discount off the wholesale acquisition cost of Soliris, positioning it as one of the most cost-competitive biosimilars available for the reference product.¹

“This launch is a milestone in expanding affordable treatment options for underserved patient populations,” said Thomas Rainey, senior vice president of US biosimilars at Teva. “We’re proud to introduce a more accessible therapy for patients battling life-threatening conditions like PNH, aHUS, and gMG.”

PNH and aHUS are ultrarare diseases with estimated US prevalence rates of approximately 50,000 and 5000, respectively.³ Despite eculizumab being a well-established treatment, 70% of patients who have PNH are not dosed according to the label, and two-thirds discontinue treatment within 1.5 years, often due to financial constraints. The launch of a lower-cost biosimilar offers payers a mechanism to improve long-term adherence and outcomes in these populations.

The FDA approved Epysqli in July 2024 for PNH and aHUS, followed by an expanded indication in November 2024 for gMG.² The approval marked the second for an eculizumab biosimilar, following the May 2024 approval of Bkemv (eculizumab-aeeb).⁴

The regulatory decision was based on robust analytical and clinical data demonstrating biosimilarity to Soliris. This included a phase 1 pharmacokinetic/pharmacodynamic study in healthy volunteers and a phase 3 crossover study in patients with PNH, which showed equivalent efficacy, safety, and immunogenicity.

“Epysqli has met the FDA’s rigorous biosimilarity standards,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “Our mission is to improve lives by delivering biologic medicines that are not only effective but also accessible. We are proud to now offer a cost-effective alternative in a therapeutic area where access has historically been limited.”

Epysqli marks the eighth US biosimilar approval for Samsung Bioepis, whose previous biosimilars span therapeutic areas that include oncology and immunology. The eculizumab biosimilar is also approved in Europe and South Korea, though it does not include an indication for Shiga toxin Escherichia coli–related hemolytic uremic syndrome.

Under a January 2025 strategic partnership, Teva leads US commercialization efforts, leveraging its robust sales infrastructure, while Samsung Bioepis oversees development, manufacturing, and supply. This partnership is designed to ensure efficient market access and payer adoption of Epysqli.

Biosimilars like Epysqli are poised to play an increasingly vital role in driving down specialty drug costs and expanding therapeutic access. For managed care organizations, Epysqli offers an opportunity to enhance the value of rare disease treatment while reducing budgetary impact, helping to achieve both clinical and economic sustainability in high-cost care settings.

References

1. Teva and Samsung Bioepis announce biosimilar Epysqli (eculizumab-aagh) injection now available in the United States. News release. Samsung Bioepis; April 7, 2025. Accessed April 9, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Samsung-Bioepis-Announce-Biosimilar-EPYSQLI-eculizumab-aagh-InjectionNow-Available-in-the-United-States/default.aspx

2. Jeremias S. FDA approves Epysqli as second Soliris biosimilar. The Center for Biosimilars^®. July 22, 2024. Accessed April 9, 2025. https://www.centerforbiosimilars.com/view/fda-approves-epysqli-as-second-soliris-biosimilar

3. National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. Accessed April 9, 2025. https://rarediseases.info.nih.gov/diseases/7337/index

4. Jeremias S. FDA approves first eculizumab biosimilar. The Center for Biosimilars. May 29, 2024. Accessed July 22, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eculizumab-biosimilar