FDA Greenlights Humira Biosim Cyltezo for Multiple Inflammatory Diseases

The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo™, a biosimilar to Humira®, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Moderate to severe active rheumatoid arthritis
• Moderate to severe polyarticular juvenile idiopathic arthritis**
• Active ankylosing spondylitis
• Moderate to severe active adult Crohn's disease
• Moderate to severe active ulcerative colitis

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

"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," says Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim, in a news release.

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 our biosimilar candidate in 2017.