Organon has acquired the regulatory and commercial rights to TOFIDENCE, a biosimilar to ACTEMRA, from Biogen. The first approved tocilizumab biosimilar in the U.S. market, TOFIDENCE was launched in May 2024 and addresses conditions that disproportionately affect women, such as rheumatoid arthritis and juvenile idiopathic arthritis.
“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s Chief Executive Officer. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”
TOFIDENCE is indicated for treating several conditions, including moderately to severely active rheumatoid arthritis, which predominantly affects women, as well as giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis, and COVID-19 in hospitalized adult patients. Rheumatoid arthritis, in particular, impacts women at a significantly higher rate than men, with approximately 75% of patients being female.
The product is available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. While Organon has acquired the U.S. regulatory and commercial rights, Bio-Thera Solutions Ltd. will maintain manufacturing rights for the U.S. market.
The agreement includes an upfront payment to Biogen, with Organon assuming tiered royalty payments based on net sales and annual net sales milestone payments to Bio-Thera Solutions.
