Celltrion Agrees to License Deal with J&J for U.S. Release of Autoimmune Biosimilar in 2025


South Korean pharmaceutical giant Celltrion Inc. reported on Friday that it has finalized a contract with Johnson & Johnson to distribute its biosimilar for autoimmune diseases in the United States. The agreement will allow Celltrion’s CT-P43, a ustekinumab biosimilar referencing J&J’s Stelara, to be available in the U.S. market in March 2025 upon approval from the Food and Drug Administration (FDA).

Celltrion submitted an application for CT-P43’s product license to the FDA in June. Stelara, a popular medication used to treat psoriasis, Crohn’s disease, and ulcerative colitis, generated $9.13 billion in sales for Janssen Pharmaceuticals in 2021. The material patents for Stelara will expire in the U.S. in September 2021 and in Europe in July 2024.

Celltrion stated that the deal will expand its product portfolio in the largest medicine market in the world, in addition to its antibody biosimilar Remsima, sold under the brand name Inflectra in the U.S., and strengthen its position in the global autoimmune disease treatments industry.

This photo provided by Celltrion shows its logo. (PHOTO NOT FOR SALE) (Yonhap)


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