Healthcare company Organon (NYSE:OGN) announced on Tuesday that it has acquired the US regulatory and commercial rights to TOFIDENCE, a biosimilar to ACTEMRA, from biotechnology company Biogen Inc (Nasdaq:BIIB).
TOFIDENCE, launched in May 2024, is the first FDA-approved tocilizumab biosimilar in the United States. It is indicated for multiple inflammatory conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
Under the agreement, Organon gains exclusive US rights to TOFIDENCE in three vial sizes for intravenous infusion, while Bio-Thera Solutions Ltd, the product developer, retains manufacturing rights.
Organon has made an upfront payment to Biogen and will assume Biogen's obligation to pay tiered royalties and annual net sales milestone payments to Bio-Thera Solutions.
This acquisition strengthens Organon's biosimilars portfolio and expands its presence in the US immunology market.
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