Hadlima FDA Approval History

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

FDA Approved: Yes (First approved July 23, 2019)
Brand name: Hadlima
Generic name: adalimumab-bwwd
Dosage form: Injection
Company: Organon Pharmaceuticals
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• Hadlima is indicated for:
  - 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.
• Hadlima is approved in the following dosage forms:
  

  Product Presentation	Strength	Biosimilar / Interchangeable
  Single-Dose Vial	40 mg / 0.8 mL	Interchangeable
  Pre-Filled Syringe	40 mg / 0.4 mL	Interchangeable
  Pre-Filled Syringe	40 mg / 0.8 mL	Interchangeable
  Autoinjector	40 mg / 0.4 mL	Interchangeable
  Autoinjector	40 mg / 0.8 mL	Interchangeable

• Hadlima is administered via subcutaneous injection.
• The FDA approval of Hadlima was based on clinical data that demonstrates Hadlima is biosimilar to Humira.
• The product label for Hadlima contains a Boxed Warning to alert health care professionals and patients about the increased risk of serious infections and malignancies.
• Most common adverse reactions (incidence >10%) include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.
• Hadlima is the fourth FDA-approved adalimumab biosimilar.

Humira Biosimilars

Development timeline for Hadlima

Further information

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