This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.” AbbVie further states that Mylan’s U.S. license will begin on July 31, 2023. According to the press release, Mylan will pay royalties to AbbVie once its biosimilar product is launched, whereas AbbVie will make no payments to Mylan.
This is the third publicly disclosed biosimilar-related patent license agreement that AbbVie has entered into in connection with Humira®, following its global settlement last year with Amgen that permits U.S. market entry of Amgen’s Amjevita® biosimilar on January 31, 2023, and AbbVie’s global settlement earlier this year with Samsung Bioepis that permits U.S. entry on June 30, 2023. According to today’s press release, Mylan’s U.S. license date will not be accelerated by Amgen’s or Samsung Bioepis’ entry.