AbbVie and Fresenius Kabi Settle Adalimumab Biosimilar Patent Disputes

Abbvie and Fresenius Kabi have announced today that they entered into a worldwide settlement and licensing arrangement resolving all intellectual property-related litigation concerning Fresenius’s MSB11022, a biosimilar candidate of AbbVie’s HUMIRA (adalimumab).

According to the press releases, under the terms of the royalty-bearing settlement and license agreements, AbbVie has granted Fresenius a non-exclusive license to AbbVie’s intellectual property relating to adalimumab.  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 the EU, Fresenius may launch upon EMA approval.  According to its press release, Fresenius expects a European launch in the first half of 2019.  AbbVie’s press release notes that it will make no payments to Fresenius under the agreement, but that the precise terms are confidential between the parties.

This follows on the heels of another settlement between AbbVie and Sandoz, which we previously reported on here, as well as other global adalimumab settlements with Amgen, Samsung Bioepis, and Mylan over the past thirteen months.

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