Samsung Bioepis Co. has entered into an agreement with Teva Pharmaceutical Industries for the licensing, development, and commercialization of EPYSQLI, a biosimilar to Soliris, in the U.S. Under this agreement, Samsung Bioepis will manage the development, regulatory registration, manufacturing, and supply chain of the product, while Teva will handle its commercialization within the U.S. The financial details of this agreement have not been disclosed.
In the United States, the FDA approved EPYSQLI as a biosimilar to Soliris in July 2024. It is intended for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis and for atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy. The approval was further expanded in November 2024 to include the treatment of generalized myasthenia gravis in adult patients who test positive for anti-acetylcholine receptor antibodies.
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