Cyltezo FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 20, 2023.
FDA Approved: Yes (First approved August 25, 2017)
Brand name: Cyltezo
Generic name: adalimumab-adbm
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody interchangeable biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
- Cyltezo is a biosimilar to Humira and has an interchangeability designation.
- Cyltezo is a citrate-free formulation approved in the following dosage forms:
- Single-dose prefilled pen (Cyltezo Pen): 40 mg/0.8 mL
- Single-dose prefilled glass syringe: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL
- Cyltezo is administered via subcutaneous injection.
- The FDA approval of Cyltezo was based on analytical, nonclinical, pharmacokinetic and clinical data supporting biosimilarity to the reference product Humira. Safety and immunogenicity were also comparable.
- Cyltezo comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies.
- The most common reported side effects include infections (including upper respiratory, sinusitis), injection site reactions, headache, and rash.
- Cyltezo is the second FDA-approved adalimumab biosimilar, following the approval of Amjevita (adalimumab-atto) in 2016.
Development timeline for Cyltezo
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
