Hadlima FDA Approval History
Last updated by Judith Stewart, BPharm on April 30, 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 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:
Product Presentation Strength Biosimilar / Interchangeable Single-Dose Vial 40 mg / 0.8 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 Biosimilar - 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
| Date | Article |
|---|---|
| Aug 17, 2022 | Approval Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration Humira® Biosimilar Hadlima™ (adalimumab-bwwd) |
| Jul 23, 2019 | Approval FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira |
Further information
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