HQ Team
April 2, 2025: Organon has acquired the commercial rights for a biosimilar for intravenous infusion in treating arthritis and Covid-19 from Biogen Inc., for an undisclosed amount.
Tofidence, the biosimilar, is used in certain patients to treat moderate to severe active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and Covid-19, according to an Organon statement.
It was the first approved tocilizumab biosimilar entrant in the US market and was introduced in May 2024.
“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.”
Regulatory rights
Organon acquired the regulatory and commercial rights to Tofidence in the US, available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution before 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.
The biosimilar (tocilizumab) is a treatment developed as a biosimilar to the reference product Actemra and also used to treat coronavirus disease 2019 in hospitalised adult patients receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The US prescribing information for Tofidence includes a boxed warning for the risk of serious infections that may lead to hospitalisation or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections.
