AbbVie, Samsung Bioepis Reach Settlement on Biosimilar of AbbVie’s Humira
AbbVie has announced the global resolution of all intellectual property-related litigation with Samsung Bioepis, a joint venture between Samsung BioLogics, an Incheon, South Korea-based contract biologics manufacturer, and Biogen, over Samsung Bioepis’ proposed biosimilar adalimumab product. Adalimumab is the active ingredient in AbbVie’s Humira, an anti-inflammatory drug with multiple indications and the company’s top-selling drug with 2017 global sales of $18.43 billion.
Under the terms of the settlement agreements, AbbVie will grant to Samsung Bioepis a non-exclusive license to AbbVie’s intellectual property relating to Humira beginning on certain dates in certain countries in which AbbVie has intellectual property. In the US, Samsung Bioepis’ license period will begin on June 30, 2023. In most countries in the European Union (EU), the license period will begin on October 16, 2018. Samsung Bioepis received EU approval for Imraldi, its biosimilar referencing adalimumab, in August 2017.
In September 2017, AbbVie announced a global resolution with Amgen on Amgen’s proposed biosimilar adalimumab product to allow it to enter the US market on January 31, 2023. AbbVie says that Samsung Bioepis’ US license date will not be accelerated upon Amgen’s entry.
Under the terms of the agreement, Samsung Bioepis will pay royalties to AbbVie for licensing its Humira patents once its adalimumab biosimilar product is launched. As with the prior Amgen resolution, AbbVie will make no payments to Samsung Bioepis. All litigation pending between the parties as well as all litigation with Samsung Bioepis’ European partner, Biogen, will be dismissed. The precise terms of the agreements were not disclosed.