Deal applies to the United States and other countries around the world.
Humira (adalimumab) is an immunosuppressive drug marketed by AbbVie and approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and other related disease. The fully human monoclonal antibody is an anti-inflammatory drug that binds to tumor necrosis factor alpha (TNF-α), preventing an inflammatory response from occurring.
Biosimilars of Humira have been marketed outside the United States for several years. The first U.S. Food and Drug Administration approval for an adalimumab biosimilar went to Amgen for Amjevita in 2016. Boehringer Ingelheim received FDA approval for its biosimilar Cyltezo in 2017, and Adalimumab biosimilars were recently approved in 2018 in Europe.
Now, AbbVie has agreed to license its Humira patents to Pfizer for its proposed adalimumab product. As part of the deal, Pfizer will receive a non-exclusive license to AbbVie's intellectual property relating to Humira in the United States beginning on November 20, 2023. In European countries, Pfizer will be able to launch its biosimilar once it receives approval from the European Medicines Agency.
In addition, AbbVie will receive royalty payments. Pfizer has also acknowledged the validity of the licensed patents.