AbbVie announced yesterday patent license agreements with Mylan over its proposed biosimilar adalimumab product. 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.

Mylan’s US license will begin on July 31, 2023, and will not be accelerated by Amgen’s or Samsung Bioepis’ entry.  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.  

“AbbVie’s HUMIRA patents reflect the groundbreaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation,” said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie.  “We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its HUMIRA biosimilar maintains that balance.”

On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the US on January 31, 2023, and on April 5, 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the US on June 30, 2023.