U.S. License Holder:
Sandoz Inc.
Date of License:
October-30-2018 (Low Concentr.); March-20-2023 (High Concentr.); May-13-2024 (Interchangeable)
Last Update:
July-31-2025
FDA-Approved Indications
HYRIMOZ (adalimumab-adaz) is a tumor necrosis factor (TNF) blocker indicated for treatment of:
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 rheumatoid arthritis;
Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older;
Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis;
Reducing signs and symptoms in adult patients with active ankylosing spondylitis;
Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;
Treatment of moderately to severely active ulcerative colitis in adults patients;
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;
Treatment of moderate to severe hidradenitis suppurativa in adult patients;
Treatment of non-infectious intermediate, posterior and panuveitis in adult patients.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Hyrimoz® (Sandoz Canada) (November-2020)
Biosimilars Approved In The E.U.
Hyrimoz® (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)
Biosimilars Approved In Australia
Hyrimoz® (Sandoz) (May-2019)
Inter Partes Review Proceedings
U.S. Patent Litigations
