Teva and Samsung Bioepis announce biosimilar Epysqli (eculizumab-aagh) injection now available in the United States

Teva Pharmaceutical Industries Ltd. , and Samsung Bioepis Co., Ltd. announced the availability of Epysqli (eculizumab-aagh) in the U.S. Epysqli is a biosimilar to Soliris (eculizumab) for the treatment of 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.Epysqli will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris, offering one of the greatest cost-saving biosimilars to Soliris in the U.S.

“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, U.S. Biosimilars at Teva. “We  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.”

“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. “Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines. We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.,” she added.

Alexion Pharmaceuticals had reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s blockbuster antibody treatment for the blood disease paroxysmal nocturnal haemoglobinuria (PNH). The agreement prevents Amgen’s biosimilar version of Soliris from entering the US market until 2025.