Settlement of litigation between Samsung Bioepis and AbbVie relating to adalimumab biosimilar,Imraldi.

AbbVie announced global resolution of all intellectual property-related litigation with Samsung Bioepis over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Samsung Bioepis a non-exclusive license to AbbVie's intellectual property relating to Humira beginning on certain dates in certain countries in which AbbVie has intellectual property: In the U.S., Samsung Bioepis' license period will begin on 30 June 2023. In most countries in the European Union, the license period will begin on 16 October 2018. On 28 September 2017, AbbVie announced a global resolution with Amgen to enter the U.S. market on 31 January 2023. Samsung Bioepis' U.S. license date will not be accelerated upon Amgen's entry.

Under the terms of the agreement, Samsung Bioepis will pay royalties to AbbVie for licensing its Humira patents once its adalimumab biosimilar product is launched. As with the prior Amgen resolution, AbbVie will make no payments to Samsung Bioepis. All litigation pending between the parties, as well as all litigation with Samsung Bioepis' European partner, Biogen, will be dismissed. The precise terms of the agreements are confidential.

Comment: Analysts consider that it now seems increasingly unlikely that other biosimilar developers will be able to negotiate for U.S. launch dates earlier than 2023.