Boehringer Ingelheim receives FDA approval for Cyltezo, a biosimilar to Humira

September 5, 2017 1:36 PM


Boehringer Ingelheim Pharmaceuticals, Inc. last week announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira. 

The biosimilar product is approved for the treatment of multiple chronic inflammatory diseases, including:

  • moderate to severe active rheumatoid arthritis
  • moderate to severe polyarticular juvenile idiopathic arthritis
  • active psoriatic arthritis
  • active ankylosing spondylitis (an arthritis that affects the spine)
  • moderate to severe active adult Crohn’s disease
  • moderate to severe active ulcerative colitis
  • moderate to severe plaque psoriasis

“Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira.

The European Medicines Agency is expected to provide an opinion on the marketing authorization application for BI’s biosimilar candidate in 2017.

Cyltezo is not commercially available at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of Cyltezo, as another delivery option for patients.


Source: BI press release

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