Amgen, AbbVie settle Humira biosimilar dispute

Amgen Inc. (NASDAQ:AMGN) has agreed to delay until early 2023 the U.S. launch of its biosimilar version of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV) in a deal announced Sept. 28 that resolves patent litigation between the companies. Amgen will pay AbbVie undisclosed royalties in exchange for a non-exclusive license to Humira patents and rights to launch its biosimilar in the EU on Oct. 16, 2018, and in the U.S. on Jan. 31, 2023. AbbVie declined to disclose whether the royalties would cover sales in both regions.

Amgen spokesperson Kelley Davenport told BioCentury that the ten Humira patents at issue in the newly resolved litigation had expiration dates ranging from 2022 to 2033, and that Amgen's non-exclusive license covers IP that extends beyond the agreed upon launch dates. Davenport said it is too early to discuss pricing details for Amgen's biosimilar, ABP 501...