Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale of the product worldwide, on a country-by-country basis. Amgen states that it expects to launch its product in Europe on Oct. 16, 2018, and in the United States on Jan. 31, 2023.
The FDA approved AMJEVITA on September 23, 2016. As we previously reported, AbbVie filed a BPCIA complaint against Amgen on August 4, 2016. AbbVie had asserted 10 patents as part of the first- wave litigation but, according to its complaint, had identified 51 other patents that it could assert against Amgen in a second-wave litigation. A 20-day bench trial was scheduled for November 4, 2019.
AbbVie’s BPCIA litigation against Boehringer Ingelheim (BI) regarding BI’s aBLA for a biosimilar version of Humira remains pending.