Why did US biosimilars arrive five years after Europe's?
AbbVie filed ~250 patents — 90% post-approval — creating a 'patent thicket' that made litigation impractical; all eight challenger companies settled for 2023 US launch dates, while European biosimilars launched in 2018 and cut AbbVie's European price by up to 80%.
Humira's core patent expired in the US in 2016, but AbbVie had filed some 250 patents, about 90% after approval, creating a "patent thicket." Rather than litigating dozens of patents, biosimilar makers settled. AbbVie reached settlements with eight companies, all agreeing to US launch dates in 2023, starting with Amgen's Amjevita on January 31. In Europe, where the patent landscape differed, biosimilars launched in October 2018. Within four months they had about 15% of the European market, and AbbVie cut its European price by up to 80%. Congressional proposals would cap the number of patents asserted against biosimilars; one would have cut AbbVie's assertable Humira patents from 105 to 24.