FDA Approves Cyltezo as Interchangeable Biosimilar with Humira

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

FDA announced on Oct. 18, 2021, that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as an interchangeable biosimilar for Humira (adalimumab). This designation indicates that adalimumab-adbm has no clinically meaningful differences from adalimumab.

Following this designation, adalimumab-adbm is approved for:

  • moderate to severe rheumatoid arthritis in adult patients
  • psoriatic arthritis in adult patients
  • ankylosing spondylitis in adult patients
  • moderate to severe ulcerative colitis in adult patients
  • moderate to severe chronic plaque psoriasis in adult patients
  • severe polyarticular juvenile idiopathic arthritis in patients two years or older
  • Crohn's disease in patients six years or older.

Adalimumab-adbm is the second interchangeable biosimilar to be approved by FDA, and the first interchangeable monoclonal antibody. FDA has approved a total of 31 interchangeable products.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said Janet Woodcock, acting FDA commissioner, in an agency press release. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”

Source: FDA