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Hyrimoz FDA Approval History

Last updated by Judith Stewart, BPharm on May 25, 2023.

FDA Approved: Yes (First approved October 30, 2018)
Brand name: Hyrimoz
Generic name: adalimumab-adaz
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa

Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

  • The expected launch date for Hyrimoz is July 2023.
  • Hyrimoz is a biosimilar to Humira and does not have an interchangeability designation.
  • Hyrimoz is a citrate-free formulation approved in the following dosage forms:
    • Single-dose prefilled pen (Sensoready Pen): 40 mg/0.8 mL, 40 mg/0.4 mL and 80 mg/0.8 mL
    • Single-dose prefilled glass syringe (with BD UltraSafe Passive™ Needle Guard): 20 mg/0.4 mL, 40 mg/0.8 mL, 40 mg/0.4 mL and 80 mg/0.8 mL
    • Single-dose prefilled glass syringe: 10 mg/0.2 mL, 10 mg/0.1 mL and 20 mg/0.2 mL
  • Hyrimoz is administered via subcutaneous injection.
  • The FDA approval of Hyrimoz was based on analytical, nonclinical, pharmacokinetic and clinical data supporting biosimilarity to the reference product Humira. Safety and immunogenicity were also comparable.
  • Hyrimoz comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies.
  • The most common reported side effects include infections (including upper respiratory, sinusitis), injection site reactions, headache, and rash.
  • Hyrimoz is the third FDA-approved adalimumab biosimilar, following the approvals of Amjevita (adalimumab-atto) in 2016, and Cyltezo (adalimumab-adbm) in 2017.

Development timeline for Hyrimoz

Mar 21, 2023Approval Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation
Oct 31, 2018Approval FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira

Further information

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