Biologics

FDA Approves Boehringer Ingelheim Humira Biosimilar

David McFarland

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FDA has approved a Boehringer Ingelheim Pharmaceuticals BLA for Cyltezo, a biosimilar version of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. Cyltezo is approved for the following indications in adult patients:

  • moderately to severely active rheumatoid arthritis;
  • active psoriatic arthritis;
  • active ankylosing spondylitis (an arthritis that affects the spine);
  • moderately to severely active Crohn’s disease; 
  • moderately to severely active ulcerative colitis; and
  • moderate to severe plaque psoriasis.

The approval was based on a submitted data package, including analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira, according to the company. The biosimilar product will not be commercially available at this time because Boehringer Ingelheim is currently involved in patent litigation with AbbVie.

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