FDA Approves Cyltezo, Second Biosimilar Humira

August 28, 2017

Biosimilars Team

The Food and Drug Administration (FDA) has approved the tumor necrosis factor blocker Cyltezo (adalimumab-adbm, Boehringer Ingelheim), a biosimilar to Humira (adalimumab, AbbVie Inc.). It is the second biosimilar to Humira; Amjevita (adalimumab-atto, Amgen, Inc.) was approved in September 2016.

Cyltezo is approved for seven indications included in the reference product label:

  • Moderately to severely active rheumatoid arthritis in adults.
  • Active psoriatic arthritis in adults.
  • Active ankylosing spondylitis in adults.
  • Moderately to severely active Crohn’s disease in adults.
  • Moderately to severely active ulcerative colitis in adults.
  • Moderate to severe plaque psoriasis in adults.
  • Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.

Detailed information about the approved uses is provided in the full prescribing information. Cyltezo is not approved as an interchangeable product.

Like Humira and Amjevita, Cyltezo contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections that may lead to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. Cyltezo must be dispensed with a patient Medication Guide that describes important information about its uses and risks.