FDAnews Drug Daily Bulletin

Amgen to Delay Humira Biosimilar Until 2023 in Deal With AbbVie

Oct. 4, 2017

Amgen has agreed to delay U.S. sales of its cheaper biosimilar to AbbVie’s Humira for the next six years under a settlement with AbbVie.

Amgen agreed to shelve its Humira biosimilar through Jan. 31, 2023. The settlement terminates all pending patent lawsuits between the companies and entitles AbbVie to undisclosed royalties from the Amgen product. Amgen will grant patent licenses for the biosimilar, Amgevita, on a country-by-country basis.

The settlement will allow Amgen to sell its biosimilar in the European market beginning on Oct. 16, 2018. The company was the first to win approval to market a Humira biosimilar in the U.S., but had delayed it until it resolved the patent litigation. AbbVie has held market exclusivity on the drug for the past 15 years.

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