Soliris Biosimilar Now Available in the U.S.

Rare Daily Staff

Teva and Samsung Bioepis said their Epysqli, a biosimilar for Soliris, is now available in the United States.

The U.S. Food and Drug Administration previously approved Epysqli to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.

Epysqli is a monoclonal antibody and anti-C5 complement inhibitor. It is a biosimilar of Soliris (eculizumab), a well-established standard of care to treat PNH and aHUS.

Unlike generic drugs, which are chemically synthesized and identical to the innovator products for which they provide a lower-priced alternative, biosimilars are not identical to their branded counterparts because biologics are produced from living cells. Biosimilars have no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies.

In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of Epysqli in the United States. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing, and supply. Teva is responsible for commercializing the product in the United States, leveraging its experience and extensive sales and marketing infrastructure.

“Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and patients need 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,” 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.”