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Hadlima FDA Approval History

Last updated by Judith Stewart, BPharm on May 25, 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

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, and plaque psoriasis.

  • The expected launch date for Hadlima is July 2023.
  • 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 is 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

Aug 17, 2022Approval Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration Humira® Biosimilar Hadlima™ (adalimumab-bwwd)
Jul 23, 2019Approval FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira

Further information

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