Organon has announced the acquisition of the US regulatory and commercial rights for intravenous infusion of the Actemra biosimilar, Tofidence, from Biogen.
The move is set to bolster and widen Organon’s US biosimilars immunology portfolio with multi-indication arthritis treatment.
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Launched in May 2024, Tofidence is available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, for further dilution before intravenous infusion.
It is the first tocilizumab biosimilar to enter the US market, and treats systemic juvenile idiopathic arthritis, moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and Covid-19.
Organon will make an upfront payment to Biogen and is committed to making tiered royalty payments based on net sales and milestone payments to Bio-Thera Solutions.
Bio-Thera Solutions, the developer of Tofidence, will continue to have the manufacturing rights for the biosimilar in the US market.
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By GlobalDataOrganon CEO Kevin Ali stated, “Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio.
“We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”
In September 2023, Biogen announced the receipt of US Food and Drug Administration (FDA) approval for Tofidence.
The biosimilar’s commercialisation and licence agreement between Biogen and Bio-Thera was established in April 2021, granting Biogen exclusive regulatory, manufacturing and commercial rights to Tofidence in all nations except China, inclusive of Taiwan, Macau and Hong Kong.
Organon’s portfolio includes medicines and products in therapeutic areas such as women’s health, and biosimilars. The company is headquartered in Jersey City, New Jersey, US.
Organon previously completed the acquisition of the Roivant subsidiary, Dermavant Sciences, broadening its dermatology portfolio.
