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FDA approves Cyltezo®

Aug 29, 2017

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.