Celltrion Inc. secured US regulatory approval for its biosimilar version of Johnson & Johnson’s blockbuster drug Stelara, setting the stage for potential market entry early next year.
The South Korean biotech company received Food and Drug Administration clearance for Steqeyma, adding to approvals already granted in Europe, the UK, Canada and its home market. The drug treats several autoimmune conditions including psoriasis, Crohn’s disease and ulcerative colitis.
The timing of Steqeyma’s US launch hinges on ongoing patent settlement negotiations with J&J. Celltrion aims to begin sales in February 2025, though specific terms haven’t been disclosed.
The approval marks another milestone in Celltrion’s push to capture market share in the lucrative US biosimilars market. Biosimilars are near-copies of complex biologic drugs that typically launch at lower prices than the original branded medicines.
Steqeyma’s clearance could help Celltrion challenge J&J’s grip on the autoimmune disease market. Stelara generated $9.7 billion in global sales for J&J in 2022, making it one of the company’s top-selling products.
