FDA Approves Hadlima (adalimumab) for Multiple Inflammatory Indications
The FDA has approved Hadlima (adalimumab), a tumor necrosis factor (TNF) blocker, for a broad range of inflammatory conditions. The approval covers adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, moderate to severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, and non-infectious uveitis. Additionally, it is approved for pediatric patients with polyarticular juvenile idiopathic arthritis (ages 2 and older) and moderately to severely active Crohn's disease (ages 6 and older). Hadlima is administered subcutaneously and can be used alone or in combination with other non-biologic disease-modifying antirheumatic drugs (DMARDs) or methotrexate, depending on the indication. The approval provides clinicians with a new biosimilar option for managing these chronic inflammatory diseases.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Hadlima is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis. It is also indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years and older. In adults with active psoriatic arthritis, it reduces signs and symptoms, inhibits structural damage progression, and improves physical function. For active ankylosing spondylitis, it reduces signs and symptoms. It treats moderately to severely active Crohn's disease in adults and pediatric patients 6 years and older, and moderately to severely active ulcerative colitis in adults. For plaque psoriasis, it is for adults with moderate to severe chronic disease who are candidates for systemic therapy or phototherapy. It also treats moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior, and panuveitis in adults.
Administer by subcutaneous injection. For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 40 mg every other week. Some RA patients not on methotrexate may benefit from 40 mg weekly or 80 mg every other week. For juvenile idiopathic arthritis: weight-based dosing every other week (10 mg for 10-<15 kg, 20 mg for 15-<30 kg, 40 mg for ≥30 kg). For Crohn's disease in adults: 160 mg on Day 1 (single or split), 80 mg on Day 15, then 40 mg every other week starting Day 29. Pediatric Crohn's: weight-based on Days 1 and 15, then every other week. For ulcerative colitis: same as adult Crohn's; discontinue if no clinical remission by 8 weeks. For plaque psoriasis or adult uveitis: 80 mg initial, then 40 mg every other week starting one week later. For hidradenitis suppurativa: 160 mg on Day 1 (single or split), 80 mg on Day 15, then 40 mg weekly or 80 mg every other week starting Day 29. Prior to initiation and periodically, evaluate for active tuberculosis and test for latent infection.
Trial data not available in label.
Not reported in label.
Hadlima is a TNF blocker approved for multiple inflammatory conditions. It can be used alone or with non-biologic DMARDs or methotrexate. For plaque psoriasis, it should only be used in patients who will be closely monitored with regular follow-up. Effectiveness has not been established in patients who lost response to or were intolerant to TNF blockers.
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