Biogen, Bioepis resolve dispute over Humira biosimilar

Biogen and development partner Samsung Bioepis announce the resolution of a patent dispute with AbbVie over its HUMIRA (adalimumab) biosimilar.

Under the terms of the settlement, AbbVie will grant patent licenses for the biosimilar, branded as IMRALDI, in Europe on a country-specific basis. Biogen and Samsung Bioepis will make royalty payments to AbbVie. Specific financial terms are not disclosed.

Biogen expects to launch IMRALDI, its third approved biosimilar, in Europe on October 16. BENEPALI, a biosimilar of Amgen's ENBREL (etanercept), and FLIXABI, a biosimilar of J&J's REMICADE (infliximab) were OK'd there in 2016.

The license period in the U.S. will begin on June 30, 2023. Separately, Amgen's U.S. entry will happen on January 31, 2023.

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