Sandoz Settles With AbbVie Over Humira Biosimilar, Hyrimoz

On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.

While the terms of the agreement allow for European sales of the drug to commence this month, US patients will have to wait for biosimilar adalimumab; AbbVie’s provision of a nonexclusive license to sell adalimumab will not begin in the United States until September 30, 2023. Notably, Sandoz’s adalimumab is not yet licensed in the United States, although it received the European Commission’s authorization in July 2018.

In all markets, Sandoz will pay AbbVie a royalty on sales of its drug, though the precise terms of the deal remain confidential. In a statement, AbbVie—which has been criticized for its settlements that some have called “pay-for-delay” tactics—noted that it will make no payments to Sandoz.

In announcing the deal, Stefan Hendriks, global head of biopharmaceuticals for Sandoz, said in a statement, "In order to realize the promise of early and expanded access and healthcare savings, biosimilars must be available as soon as possible to the patients and physicians who need them. This settlement helps remove uncertainty regarding when our biosimilar adalimumab will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease.”

The settlement comes after AbbVie filed suit against Sandoz in New Jersey district court in August of this year, alleging patent infringement under the Biologics Price Competition and Innovation Act. The 2 companies engaged in the beginning stages of the so-called “patent dance,” or information exchange process, provided for under the act, but AbbVie alleged that although the parties began exchanging information in January 2018, Sandoz did not provide information regarding the processes used to manufacture its biosimilar in these meetings.

The Sandoz—AbbVie settlement closely mirrors deals struck between AbbVie and other biosimilar developers; agreements between the Humira maker and Mylan allow for a US license term to begin on July 31, 2023; a deal with Samsung Bioepis allows for US marketing on June 30, 2023; and a deal with Amgen allows for US marketing on January 31, 2023.