Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for its commercialization in all approved markets worldwide. SB5 has already received marketing authorization from the European Commission (EC) as Imraldi®, but has not yet received regulatory approval in the U.S.
The companies’ press releases indicate that, under the terms of their agreement, SB5 may be launched in most countries in the European Union beginning on October 16, 2018 and, if approved by FDA, in the United States beginning on June 30, 2023. According to Samsung Bioepis, Imraldi® will be commercialized in Europe by Biogen. According to AbbVie: “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 are confidential.”
Samsung Bioepis’ U.S. license date is five months later than the license date that AbbVie agreed to regarding Amgen’s adalimumab biosimilar, Amjevita. As we previously reported, on September 28, 2017, AbbVie and Amgen announced that they had reached a global resolution of their dispute that permits Amgen to launch Amjevita in the U.S. on January 31, 2023 (and, like Samsung Bioepis, in Europe on October 16, 2018). According to AbbVie’s press release today, Samsung Bioepis’ U.S. license date will not be accelerated upon Amgen’s entry.
AbbVie’s litigation against Boehringer Ingelheim (BI) relating to BI’s aBLA for its adalimumab biosimilar, Cyltezo, remains ongoing.
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