HUMIRA

What it is

Humira is adalimumab, a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Humira binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use pre-filled glass syringe or as a single use, pre-filled pen (Humira Pen).

Approved indications

— Reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. — Reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs. — Treatment of enthesitis-related arthritis in children who have had an inadequate response to, or who are intolerant to, conventional therapy. — Treatment of signs and symptoms and inhibiting the progression of structural damage of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate. — Reducing signs and symptoms in patients with active ankylosing spondylitis. — Treatment of moderate to severe Crohn's disease to reduce signs and symptoms and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies or who have lost response to or are intolerant to infliximab. — Treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. — Treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. — Treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy. — Treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy. — Treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate. — Treatment of chronic non-infectious anterior uveitis in paediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Dosing overview

Humira is administered by subcutaneous injection. The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose. Some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosage of Humira to 40 mg every week, or 80 mg fortnightly. For patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis, the dose is based on weight: 10 kg to less than 30 kg receives 20 mg fortnightly, and 30 kg or more receives 40 mg fortnightly. The recommended dose of Humira for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose. The recommended dose of Humira for patients with ankylosing spondylitis is 40 mg adalimumab administered every fortnight as a single dose.

Key safety warnings

New injections should never be given into areas where the skin is tender, bruised, red or hard. Humira should not be mixed in the same syringe with any other medicine. Humira contains no antimicrobial agent and any residue should be discarded.

PBS listing

Humira is listed on the PBS in multiple presentations: 20 mg in 0.2 mL pre-filled syringe (22 items, A$567.42 ex-manufacturer price), 40 mg in 0.4 mL pre-filled syringe (41 items, A$444.17), 40 mg in 0.4 mL pre-filled pen (44 items, A$444.17), 80 mg in 0.8 mL pre-filled syringe (8 items, A$618.90), and 80 mg in 0.8 mL pre-filled pen (8 items, A$618.90). All presentations require authority required restriction, with streamlined status available for the 20 mg, 40 mg syringe and 40 mg pen formulations.

Regulatory history

Humira 40 mg pre-filled syringe and pen were first listed on the ARTG on 16 November 2017, followed by the 80 mg syringe and pen on 3 January 2018, and the 20 mg syringe on 28 February 2018. In March 2016, the PBAC recommended listing of adalimumab for treatment of moderate to severe ulcerative colitis. In November 2017, the PBAC recommended a price reduction across multiple indications due to biosimilar entry and recommended an amendment to allow adalimumab as first-line biological disease-modifying anti-rheumatic drug for rheumatoid arthritis. In July 2018, the PBAC recommended authority required listings for new forms and strengths on a cost-neutral basis. In July 2025, the PBAC recommended changes to paediatric chronic plaque psoriasis, enthesitis and spondylitis-related juvenile idiopathic arthritis, and juvenile idiopathic arthritis listings.