AbbVie announced it reached a global resolution for all intellectual property-related litigation with the two companies regarding its biosimilar Imraldi (adalimumab).
Under terms of the settlement, AbbVie said it will grant Samsung Bioepis a non-exclusive license to AbbVie’s intellectual property relating to Humira beginning on June 30, 2023, in the United States.
AbbVie has been desperately trying to fend off biosimilar challenges to its blockbuster rheumatoid arthritis treatment. Last year Humira generated $18.43 billion for AbbVie – nearly two-thirds of the company’s net revenue. Biosimilar competition is becoming fierce as multiple companies are fighting for space to develop biosimilar therapies that will challenge traditional drugs manufactured by rival companies.
In August Samsung Bioepis received marketing authorization in Europe for Imraldi for the treatment of rheumatoid arthritis. As part of its deal with AbbVie. the licensing agreement will be granted on a country-by-country basis in Europe beginning in October of this year.
Samsung Bioepis will pay undisclosed royalties to AbbVie for licensing its Humira patents once its adalimumab biosimilar product is launched, AbbVie said. The deal is similar to one struck between AbbVie and Amgen. The Amgen biosimilar will be able to launch in January of 2023. Samsung Bioepis’ U.S. license date will not be accelerated due to Amgen’s ability to sell its biosimilar in January.
Amgen will also be able to sell its biosimilar in Europe beginning in October as well, the same day that Samsung Bioepis was provided in its settlement.