pharm edaily

[Lim Jeong-yeo, Edaily Reporter] EPYSQLI, a biosimilar to Soliris, is now available in the U.S. for 30% discounted price to the original, Teva Pharmaceuticals and Samsung Bioepis announced Tuesday.

EPYSQLI is a biological treatment for rare diseases such as 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.

EPISQLI(Photo=Samsung Bioepis)

“Individuals living with rare diseases 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,” Rainey said.

“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.

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.

Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label. Two-thirds of patients discontinue eculizumab within an average of 1.5 years, which can be attributed to several factors including high treatment cost.

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. The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients, Samsung Bioepis emphasized.

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.