Big Molecule Watch
October 28, 2016

Amgen: Unlikely to Launch Amjevita® Biosimilar Before 2018

At yesterday’s earnings call for Q3 2016, Amgen indicated that, due to its ongoing litigation with AbbVie, Amgen is unlikely to launch Amjevita® (adalimumab-atto), its FDA-approved biosimilar of Humira®, before 2018.  Amgen Chairman and CEO Bob Bradway stated:

In biosimilars, AMJEVITA, which is of course our biosimilar to adalimumab, is our first approval among the many biosimilar programs that we expect will help generate long-term growth at Amgen. As you know, we’re in litigation with AbbVie over AMJEVITA, and it’s safe to say that there will be more litigation before there’s a launch. Given the pace of that litigation, it’s unlikely that this matter will be clarified in time for us to launch in 2017. We’ve also successfully completed Phase III studies in two more biosimilars and look forward to their regulatory process.

Stay tuned to Big Molecule Watch for further developments.