On September 28, 2017, AbbVie and Amgen announced a global settlement of their patent dispute surrounding Amgen’s proposed biosimilar to HUMIRA. The terms of the agreement remain confidential between the parties, but according to the announcement, AbbVie will grant Amgen a non-exclusive license for the use and sale of Amgen’s biosimilar (AMGEVITA) to HUMIRA. Amgen will pay royalties under the terms of the agreement, and also acknowledged the validity of AbbVie’s patents related to HUMIRA.
Amgen stated that it expects to launch in Europe on October 16, 2018, and in the United States on January 31, 2023. As previously reported, the European Commission approved AMGEVITA for all available indications on March 23, 2017. The FDA previously approved AMGEVITA in the United States on September 23, 2016.