Abbvie v. Amgen update (Humira biosimilar lawsuit)

In its complaint regarding Amgen's biosimilar version of the drug Humira, Abbvie alleged that 42 U.S.C. § 262(l)(8)(A) requires Amgen to provide notice to AbbVie “not later than 180 days before the date of the first commercial marketing” of the Amgen biosimilar product, which can only be given after FDA licensure.   AbbVie also requested an order compelling Amgen to comply with the notice of commercial marketing provision set forth in 42 U.S.C. § 262(l)(8)(A).  On October 28, 2016, Amgen stipulated that it will comply with the notice requirements of 42 U.S.C. § 262(l)(8)(A): “The parties agree that paragraph (l)(8)(A), as currently interpreted by the courts, requires Amgen Inc., the subsection (k) applicant, to provide notice to AbbVie Inc., the reference product sponsor, only after ABP 501 (now known as Amjevitaä) is licensed by the FDA and then not later than 180 days before the date of first commercial marketing of Amjevitaä in the United States.” 

The parties have also filed a joint proposed scheduling order, which proposes a trial commencing on November 4, 2019.

Abbvie Inc. v. Amgen Inc., 16-666, U.S. District Court for the District of Delaware (Wilmington).