First Interchangeable Biosimilar to Humira Gets FDA Approval

Credit: FDA.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.

The Food and Drug Administration has approved Cyltezo® (adalimumab-adbm) as the first interchangeable biosimilar to Humira® (adalimumab).

Cyltezo, a tumor necrosis factor (TNF) blocker, is indicated to treat adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, and moderate to severe plaque psoriasis.

Cyltezo is also approved to treat moderately to severely active Crohn disease in children 6 years of age and older, as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years of age and older. 

The approval for interchangeability was based on data from the randomized, double-blind, parallel-arm, active-comparator phase 3 VOLTAIRE-X trial ( Identifier: NCT03210259), which compared the effects of Cyltezo with Humira in 238 patients with moderate to severe chronic plaque psoriasis.

Patients received Humira and were then randomly assigned to a switching group (patients switched several times between Cyltezo and Humira) or a continuous treatment group (patients received Humira continuously).

Results showed no clinically meaningful differences in pharmacokinetics, efficacy, immunogenicity, or safety between the groups.

Cyltezo is supplied in single-dose prefilled glass syringes in 2 dosage strengths: 40mg/0.8mL and 20mg/0.4mL. The product is expected to be available in July 2023.

An interchangeable biosimilar product can be substituted for the reference product without requiring a prescription change; this substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs.


  1. US FDA approves Cyltezo® (adalimumab-adbm) as first interchangeable biosimilar with Humira®. News release. Boehringer Ingelheim. October 15, 2021. Accessed October 18, 2021.
  2. Cyltezo. Package insert. Boehringer Ingelheim; 2021. Accessed October 18, 2021.