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Adalimumab biosimilars - October 2023 update

July 20, 2023

Some clinical considerations for the biosimilars

• Each is available in autoinjector and prefilled syringe forms. Abrilada and Hadlima are also available in vial form.
• The citrate-free and high-concentration forms are associated with less injection site pain. All adalimumab biosimilars are available in citrate-free form; currently only Hadlima, Hyrimoz, and Yuflyma are available in high-concentration forms (e.g., 40 mg per 0.4 mL).
• Cyltezo is currently the only adalimumab biosimilar to be designated as interchangeable with Humira. Auto-substitution rules vary by state, however.

Names and approved indications

• Amjevita (adalimumab-atto) - launched January 31 by Amgen. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; 8) uveitis in adult patients; and 9) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Cyltezo (adalimumab-adbm) - launched July 1 by Boehringer Ingelheim. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; 8) uveitis in adult patients; and 9) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Hadlima (adalimumab-bwwd) - launched July 1 by Organon and Samsung Bioepis. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; 8) uveitis in adult patients; and 9) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Hulio (adalimumab-fkjp) - launched July 3 by Biocon. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; and 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; and 8) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Hyrimoz (adalimumab-adaz) - launched July 1 by Sandoz. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adults patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; 8) uveitis in adult patients; and 9) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Idacio (adalimumab-aacf) - launched July 3 by Fresenius Kabi. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; and 7) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Yuflyma (adalimumab-aaty) - launched July 2 by Celltrion. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) anklyosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; and 8) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.
• Yusimry (adalimumab-aqvh) - launched July 3 by Coherus Biosciences. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; 8) uveitis in adult patients; and 9) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.

Pfizer's Abrilada (adalimumab-afzb) is expected to launch later this year. Indicated for 1) moderate to severe rheumatoid arthritis in adult patients; 2) psoriatic arthritis in adult patients; 3) ankylosing spondylitis in adult patients; 4) moderate to severe Crohn disease in adult and pediatric patients 6 years and older; 5) moderate to severe ulcerative colitis in adult patients; 6) moderate to severe chronic plaque psoriasis in adult patients; 7) moderate to severe hidradenitis suppurativa in adult patients; and 8) moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older.