Big Molecule Watch
October 12, 2018

AbbVie and Sandoz Settle Adalimumab Biosimilar Patent Disputes

On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz, a proposed biosimilar of Humira® (adalimumab).  According to the press releases, under the terms of the royalty-bearing settlement agreements, AbbVie is granting to Sandoz a non-exclusive license to AbbVie’s intellectual property relating to adalimumab, and all litigation pending between the parties will be dismissed.  In the U.S., the license period will begin on September 30, 2023, and will not be accelerated by the entry of companies who have already taken a license.  In Europe, where Sandoz recently received approval, Sandoz’s license will begin on October 16, 2018 in most European countries.  The press releases note that AbbVie will make no payments to Sandoz under the agreements, the precise terms of which are confidential between the parties.

This is the fourth global resolution that AbbVie has reached concerning a biosimilar of Humira®, following its agreements with Amgen, Samsung Bioepis and Mylan over the past thirteen months.  Sandoz’s U.S. license date of September 30, 2023 is later than the licensed entry dates for Amgen’s FDA-approved Amjevita (adalimumab-atto) (January 31, 2023); Samsung Bioepis’ SB5 biosimilar candidate (June 30, 2023); and Mylan’s MYL1401A biosimilar candidate (July 31, 2023).

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