Organon (NYSE: OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
“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.”
Under the terms of the agreement, Organon has acquired the regulatory and commercial rights to TOFIDENCE in the U.S., available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution prior to intravenous infusion. Bio-Thera Solutions Ltd., the product developer, will maintain manufacturing rights for TOFIDENCE for the U.S. market.
The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions Ltd.
TOFIDENCE (tocilizumab) is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and Coronavirus Disease 2019.
