By Fineline Cube 
Organon (NYSE: OGN) announced today that it has acquired regulatory and commercial rights in the U.S. for TOFIDENCE, a biosimilar to ACTEMRA, from Biogen Inc. (NASDAQ: BIIB). This acquisition follows an agreement where Bio-Thera Solutions Ltd., the developer of TOFIDENCE, granted Biogen exclusive rights to the product in global markets excluding China in April 2021.
Agreement Details
Under the terms of the agreement, Organon has obtained regulatory and commercial rights to TOFIDENCE in the U.S., while Bio-Thera will retain manufacturing rights for the U.S. market. The deal 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.
Product Profile
TOFIDENCE, the first approved tocilizumab biosimilar in the U.S. market, was launched in May 2024. It is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.-Fineline Info & Tech