AbbVie Signs Patent License with Mylan for Humira Biosimilar

July 18, 2018

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

On July 17, 2018, AbbVie announced that it signed patent license agreements with Mylan over Mylan’s proposed biosimilar to AbbVie’s Humira (adalimumab). AbbVie’s product made $18.43 billion in 2017 sales.

Under the terms of the agreements, AbbVie will 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. 

According to AbbVie, Mylan's US license will begin on July 31, 2023 and will not be accelerated by the entries of Amgen's or Samsung Bioepis' Humira biosimilar products.  Mylan will pay royalties to AbbVie for licensing its Humira patents once Mylan’s 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 to enter the US on January 31, 2023, and in April 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the US on June 30, 2023.

Source: AbbVie