AbbVie Settles With a Third Biosimilar Developer Over Humira

Drug maker AbbVie, sponsor of the top-selling adalimumab (Humira), has settled with a third biosimilar developer seeking to launch a competitive product.

AbbVie announced Tuesday morning that it has reached a patent license agreement with biosimilar developer Mylan over an as-yet unapproved adalimumab molecule.

Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.

Notably, no deal was announced concerning marketing of an adalimumab product in the European Union, where the European Medicines Agency is actively reviewing the proposed adalimumab biosimilar FKB327, developed by Fujifilm Kyowa Kirin Biologics and slated to be commercialized by Mylan. A regulatory decision on FKB327 is expected before the end of this year.

The US settlement follows similar settlements between AbbVie and biosimilar developers; in April 2018, the Humira maker announced a deal with Samsung Bioepis and Biogen concerning Imraldi, an adalimumab biosimilar that is approved in the European Union, although it has not yet been approved by the FDA. Under the terms of the Samsung Bioepis and Biogen deal, AbbVie will grant patent licenses for the product in Europe on a country-by-country basis beginning on October 16, 2018. In the United States, should the drug be approved, the partnership will be permitted to market the biosimilar beginning on June 30, 2023.

Earlier, in September 2017, Amgen announced that it had reached a deal with AbbVie that would allow it to launch its biosimilar, Amgevita, in the European Union on October 16, 2018, and in the United States (under the slightly different name Amjevita) on January 31, 2023.

Today’s deal comes as AbbVie faces increased scrutiny of such settlements; this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, urged the Federal Trade Commission (FTC) to investigate whether settlements over Humira or other high-cost biologic drugs are “pay-for-delay” tactics that keep consumers from accessing cheaper biosimilars in a timely way. Also calling on the FTC to investigate AbbVie’s settlements is the patient advocacy group Patients for Affordable Drugs, which has called the deals anticompetitive.

AbbVie has objected to characterizations of its settlements as “pay-for-delay” tactics, saying that “AbbVie is not paying Amgen or Samsung Bioepis, and in fact both Amgen and Samsung Bioepis will be paying royalties to AbbVie once their adalimumab biosimilar products launch in the [United States].”