Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®. This is the first biosimilar from BI to be FDA approved. According to the release:
Cyltezo® is not yet commercially available due to the active patent litigation between Boehringer Ingelheim and AbbVie.
EMA is expected to provide an opinion on BI’s EU application in 2017.