Hadlima FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 20, 2023.
FDA Approved: Yes (First approved July 23, 2019)
Brand name: Hadlima
Generic name: adalimumab-bwwd
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
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 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 a biosimilar to Humira and does not have an interchangeability designation.
- Hadlima is approved in the following dosage forms:
- Single-dose prefilled autoinjector (Hadlima PushTouch): 40 mg/ 0.8 mL
- Single-dose prefilled glass syringe: 40 mg/0.8 mL
- Single-dose glass vial for institutional use only: 40 mg/0.8 mL
- Single-dose prefilled autoinjector (Hadlima PushTouch): 40 mg/ 0.4 mL
- Single-dose prefilled glass syringe: 40 mg/0.4 mL
- 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
