AbbVie To Grant Mylan License to Launch Humira BiosimilarBy
AbbVie has signed patent license agreements with Mylan over Mylan’s proposed biosimilar to AbbVie’s Humira (adalimumab). Humira is AbbVie’s top-selling drug with 2017 sales of $18.43 billion.
Under the agreements, AbbVie will grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to Humira in the US and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.
Mylan’s US license will begin on July 31, 2023, and will not be accelerated by the entry of Amgen’s or Samsung Bioepis’ Humira biosimilar. Mylan will pay royalties to AbbVie for licensing its Humira patents once its biosimilar product is launched. Mylan acknowledges the validity of the licensed patents. AbbVie will make no payments to Mylan.
In September 2017, AbbVie announced a global resolution with Amgen for Amgen’s Humira biosimilar to enter the US on January 31, 2023, and in April 2018, AbbVie announced a similar resolution with Samsung Bioepis for its biosimilar to enter the US on June 30, 2023.