Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced that the companies have entered into a license, development and commercialization agreement for EPYSQLI^® (eculizumab-aagh), Samsung Bioepis’ biosimilar to Soliris^®i (eculizumab) in the United States (U.S.).

Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, manufacture and supply of the product, while Teva will be responsible for commercialization of the product in the U.S. The financial terms of the agreement remain confidential.

EPYSQLI is a complement inhibitor indicated for the treatment of rare disease patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

“We are excited to announce this new strategic partnership for a biosimilar which has a significant potential to increase access for rare disease patients, who are suffering from the high-cost and the limited availability of the treatment. Rare diseases such as PNH, aHUS and gMG, pose many but unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases,” said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. “This collaboration is a testament of our long-term commitment in the biosimilars business, as a leading biopharmaceutical company with a mission to innovate access to treatments for healthcare systems, payers, providers, and patients. We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the U.S.”

Chris Fox, Executive Vice President, U.S. Commercial at Teva, said, “We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients. The collaboration enables us to leverage our extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options.”

In the U.S., EPYSQLI (eculizumab-aagh) was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris^® (eculizumab) in July 2024 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. In Europe, EPYSQLI was approved by the European Commission (EC) in May 2023, and by Korea’s Ministry of Food and Drug Safety (MFDS) in January 2024 as a biosimilar to Soliris^®. EPYSQLI has been commercially available since July 2023 in Europe and April 2024 in Korea.

This agreement is a testament to both Samsung Bioepis’ and Teva's strong track record in the field of biosimilars and the potential value that these biosimilars could deliver to patients and healthcare systems. Since the first biosimilar launch in 2015, Samsung Bioepis’ biosimilars portfolio has grown to nine biosimilars available across over 40 countries covering therapeutic areas of immunology, oncology, ophthalmology, hematology, and nephrology.ⁱⁱ Teva has a broad biosimilar portfolio, with this agreement expanding its pipeline to 18 assets across multiple therapeutic areas.