The FDA has so far approved nine biosimilars of AbbVie Inc.’s Humira (adalimumab), and all of them — as well as some others in the pipeline — have settled patent litigation with AbbVie that allows them to launch onto the U.S. markets by a certain date.
But it’s not just the launch dates that are different. Some are low-concentration versions of Humira, while some are high-concentration versions, the latter of which has about 85% of current Humira prescribing. The FDA approved a high-concentration, citrate-free version of Humira in November 2015, but AbbVie waited until July 2018 to launch it. This formulation requires half the volume of drug injected compared with the original formulation, and it has fewer excipients that often cause discomfort when injected, as well as a thinner needle.