Cyltezo FDA Approval History

Last updated by Judith Stewart, BPharm on May 27, 2025.

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 biosimilar/interchangeable 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 indicated for the treatment of:
  - Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
  - Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
  - Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
  - Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
  - Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  - Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.
  Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
  - Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
  - Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients.
  - Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
• Cyltezo is approved in the following dosage forms:

  Product Presentation	Strength	Biosimilar / Interchangeable
  Pre-Filled Syringe	10 mg / 0.2 mL	Interchangeable
  Pre-Filled Syringe	20 mg / 0.4 mL	Interchangeable
  Pre-Filled Syringe	40 mg / 0.4 mL	Biosimilar
  Pre-Filled Syringe	40 mg / 0.8 mL	Interchangeable
  Autoinjector	40 mg / 0.4 mL	Biosimilar
  Autoinjector	40 mg / 0.8 mL	Interchangeable

• 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.

Humira Biosimilars

Development timeline for Cyltezo

Further information

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