Hadlima FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 10, 2024.

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 biosimilar/interchangeable 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:
  - single-dose prefilled autoinjector (Hadlima PushTouch): 40 mg/ 0.8 mL (biosimilar)
  - single-dose prefilled glass syringe: 40 mg/0.8 mL (interchangeable)
  - single-dose glass vial for institutional use only: 40 mg/0.8 mL (interchangeable)
  - single-dose prefilled autoinjector (Hadlima PushTouch): 40 mg/ 0.4 mL (biosimilar)
  - single-dose prefilled glass syringe: 40 mg/0.4 mL (biosimilar)
• The 40 mg/0.8 mL single-dose prefilled glass syringe and single-dose glass vial have an interchangeable designation.
• 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, following the approvals of Amjevita (adalimumab-atto) in 2016, Cyltezo (adalimumab-adbm) in 2017, and Hyrimoz (adalimumab-adaz) in 2018.

Development timeline for Hadlima

Further information

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