South Korea's major pharmaceutical firm Celltrion Inc. said Friday it has completed a license deal with Johnson & Johnson to sell its autoimmune disease treatment biosimilar in the United States.
The deal will allow Celltrion's CT-P43, the company's ustekinumab biosimilar referencing Stelara, developed by J&J's pharmaceutical unit of Janssen Pharmaceuticals, to hit the U.S. market in March 2025 after winning approval from the U.S. Food and Drug Administration (FDA), according to the Korean company.
Celltrion filed an application for a product license for CT-P43 with the U.S. FDA in June.
Stelara is a blockbuster drug used to treat autoimmune diseases, including psoriasis, Crohn's disease and ulcerative colitis. According to Johnson & Johnson, sales of Stelara reached US$9.13 billion in 2021.
The material patents for Stelara are expected to expire in the U.S. in September of this year and in Europe in July 2024.
Celltrion said the deal will help the company expand its product portfolio in the world's biggest medicine market, along with its antibody biosimilar Remsima, sold under the brand name Inflectra in the U.S., and bolster its competitive edge in the global market for autoimmune disease treatments.
Source: Yonhap News Agency