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Hadlima FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 19, 2019.

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, Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

  • 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.
  • The FDA approval of Hadlima is based on clinical data that demonstrates Hadlima is biosimilar to Humira.
  • Hadlima is administered via subcutaneous injection.
  • 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

Jul 23, 2019Approval  FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira

Further information

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