Teva Pharmaceutical Industries and Samsung Bioepis have officially launched Epysqli (eculizumab-aagh), a biosimilar version of Alexion Pharmaceuticals' Soliris, in the United States. The product will be offered at a 30% discount off the wholesale acquisition cost of the reference product, potentially increasing access to treatment for patients with rare diseases.
Epysqli is indicated for the treatment of three rare conditions: 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.
Strategic Partnership to Address Rare Disease Treatment Access
Under the terms of the agreement, Samsung Bioepis is responsible for development, regulatory registration, manufacturing, and supply of Epysqli, while Teva handles commercialization in the U.S. market. This collaboration represents a significant step in expanding treatment options for patients with these rare conditions, which can be life-threatening if left untreated.
"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 of 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."
The biosimilar received FDA approval for PNH and aHUS in July 2024, with the gMG indication added in November 2024. Epysqli has been commercially available in Europe since July 2023 and in Korea since April 2024.
Clinical Significance and Disease Impact
The three conditions targeted by Epysqli represent serious rare diseases with significant health impacts:
- PNH is characterized by the destruction of red blood cells (hemolysis), blood clots, and impaired bone marrow function
- aHUS involves abnormal blood clot formation in small blood vessels throughout the body, which can lead to kidney failure
- gMG is an autoimmune neuromuscular disorder causing muscle weakness that can affect breathing and swallowing
Linda MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis, emphasized the critical nature of these conditions: "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."
Mechanism of Action and Safety Considerations
Epysqli, like its reference product Soliris, is a complement inhibitor that works by blocking a specific part of the complement system, a component of the immune system. By inhibiting the terminal complement cascade, it prevents the destruction of red blood cells in PNH, reduces thrombotic microangiopathy in aHUS, and improves neuromuscular function in gMG.
The biosimilar carries a boxed warning regarding the risk of serious meningococcal infections. Patients must be vaccinated against meningococcal bacteria at least two weeks prior to starting treatment unless the risks of delaying therapy outweigh infection risks. Due to these safety concerns, Epysqli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
Market Impact and Strategic Significance
This launch represents a significant addition to both companies' biosimilar portfolios. For Teva, it aligns with their Pivot to Growth strategy, expanding their biosimilar portfolio to 18 assets across multiple therapeutic areas. Samsung Bioepis now has nine biosimilars available across more than 40 countries in therapeutic areas including immunology, oncology, ophthalmology, hematology, and nephrology.
"Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines," MacDonald stated. "We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S."
Chris Fox, Executive Vice President of U.S. Commercial at Teva, added: "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."
Broader Context in Biosimilar Market
The launch comes at a time when biosimilars are gaining increased attention for their potential to reduce healthcare costs while maintaining comparable efficacy and safety to reference biologics. For rare disease treatments, which often come with exceptionally high price tags, biosimilars may represent a critical pathway to improved patient access.
Industry experts note that while the 30% discount is significant, the high base price of Soliris means that Epysqli will still be an expensive therapy. However, the availability of a lower-cost alternative may help ease the financial burden on patients, insurers, and healthcare systems while potentially expanding treatment to patients who previously could not access these therapies due to cost constraints.
