Big Molecule Watch
August 26, 2017

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

Today, Boehringer Ingelheim received FDA  approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab).  Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.  This is the second adalimumab biosimilar approved by the FDA.  Amgen’s Amjevita® was the first adalimumab biosimilar to receive FDA approval (September 23, 2016), but no adalimumab biosimilar is on the US market yet.

AbbVie recently filed a complaint for patent infringement under the BPCIA against Boehringer Ingelheim based on its filing of the aBLA for Cyltezo® as we reported here.

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