Samsung Bioepis Settles With AbbVie, Clearing Way for EU Launch of Adalimumab Biosimilar

Samsung Bioepis and Biogen announced today that the companies have reached a settlement with AbbVie, maker of the top-selling Humira, that will allow the partnership to launch their approved biosimilar—Imraldi—in the European Union on October 16, 2018.

According to Samsung Bioepis and Biogen, while the precise terms of the settlement remain confidential, the agreement allows the parties to dismiss all pending patent litigation concerning adalimumab. AbbVie will grant patent licenses for the sale and use of Imraldi in Europe on a country-by-country basis. Imraldi is not yet approved in the United States, but AbbVie stated that it would begin a license period for the biosimilar in the US market on June 30, 2023.

“Biogen already markets [2] biosimilars in Europe and the planned introduction of Imraldi on October 16 could potentially expand patient choice by offering physicians more options to meet the needs of patients while delivering significant savings to healthcare systems,” said Ian Henshaw, global head of biosimilars at Biogen, in a statement. Biogen has previously reported that Imraldi’s introduction could save European health systems $3.18 billion by 2020.

The newly announced settlement is similar to the one that rival biosimilar developer Amgen struck with AbbVie in September 2017; under that deal, AbbVie will grant Amgen country-specific licenses for the sale and use of its adalimumab biosimilar, Amgevita, and will permit Amgen to launch the product in the European Union on the same date as Imraldi.

Amgen’s biosimilar adalimumab is also approved by the FDA. However, under the terms of the agreement, the product—which will be sold under the slightly different name Amjevita in the US market—cannot launch in the United States before January 31, 2023. A second adalimumab biosimilar, Boehringer Ingelheim’s (BI) Cyltezo, is approved in the United States, but no settlement between BI and AbbVie has been announced, and no prospective launch date for the product has been disclosed.

Meanwhile, the price of the reference Humira continues to rise for US patients; AbbVie raised its price on the drug by 9.7% for 2018 in a move that analysts say could add $1.2 billion to the US healthcare system’s costs for the year.