Organon acquires Actemra biosimilar’s US rights from Biogen

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Wed, Apr 2, 2025, 7:01 AM 2 min read

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Organon has announced the acquisition of the US regulatory and commercialized rights for intravenous infusion of the Actemra biosimilar, Tofidence, from Biogen.

The determination is acceptable to bolster and widen Organon’s US biosimilars immunology portfolio with multi-indication arthritis treatment.

Launched successful May 2024, Tofidence is disposable successful 3 vial sizes: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, for further dilution earlier intravenous infusion.

It is the archetypal tocilizumab biosimilar to participate the US market, and treats systemic juvenile idiopathic arthritis, moderately to severely progressive rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and Covid-19.

Organon volition marque an upfront outgo to Biogen and is committed to making tiered royalty payments based connected nett income and milestone payments to Bio-Thera Solutions.

Bio-Thera Solutions, the developer of Tofidence, volition proceed to person the manufacturing rights for the biosimilar successful the US market.

Organon CEO Kevin Ali stated, “Biosimilars proceed to beryllium a cardinal maturation operator for Organon, and this acquisition complements our existing business, enabling america to grow our immunology portfolio.

“We judge that by leveraging our commercialized expertise and marketplace entree capabilities, determination is sizeable maturation imaginable for this product.”

In September 2023, Biogen announced the receipt of US Food and Drug Administration (FDA) support for Tofidence.

The biosimilar’s commercialisation and licence statement betwixt Biogen and Bio-Thera was established successful April 2021, granting Biogen exclusive regulatory, manufacturing and commercialized rights to Tofidence successful each nations but China, inclusive of Taiwan, Macau and Hong Kong.

Organon's portfolio includes medicines and products successful therapeutic areas specified arsenic women’s health, and biosimilars. The institution is headquartered successful Jersey City, New Jersey, US.

Organon antecedently completed the acquisition of the Roivant subsidiary, Dermavant Sciences, broadening its dermatology portfolio.

"Organon acquires Actemra biosimilar’s US rights from Biogen" was primitively created and published by Pharmaceutical Technology, a GlobalData owned brand.

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