AMGEVITA

What it is

AMGEVITA is a biosimilar medicine to the reference product Humira (adalimumab). AMGEVITA (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. AMGEVITA binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). AMGEVITA is a sterile, preservative free solution of adalimumab for subcutaneous administration.

Approved indications

— Moderate to severely active rheumatoid arthritis in adult patients, including those with recently diagnosed disease who have not received methotrexate, used alone or in combination with methotrexate. — Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had inadequate response to one or more disease modifying anti-rheumatic drugs, in combination with methotrexate or as monotherapy. — Enthesitis-related arthritis in children who have had inadequate response to or intolerance to conventional therapy. — Moderately to severely active psoriatic arthritis in adult patients where response to previous disease modifying anti-rheumatic drugs has been inadequate. — Active ankylosing spondylitis in adult patients. — Moderate to severe Crohn's disease in children aged 6 years and older and adults, to reduce signs and symptoms and induce and maintain clinical remission in patients with inadequate response to conventional therapies or loss of response to or intolerance of infliximab. — Moderate to severe ulcerative colitis in adult patients with inadequate response to conventional therapy or intolerance to or contraindications for such therapies. — Severe chronic plaque psoriasis in children and adolescents from 4 years of age with inadequate response or inappropriate candidates for topical therapy and phototherapy, and moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. — Active moderate to severe hidradenitis suppurativa (acne inversa) in patients aged 12 years and older with inadequate response to conventional systemic therapy. — Non-infectious intermediate, posterior and pan-uveitis in adult patients with inadequate response to corticosteroids, in need of corticosteroid sparing, or for whom corticosteroid treatment is inappropriate.

Dosing overview

The recommended dose 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 by increasing the dosage to 40 mg every week, or 80 mg fortnightly. The recommended dose for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose. The recommended dose for patients with ankylosing spondylitis is 40 mg adalimumab administered every fortnight as a single dose. For patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis, the recommended dose is based on body weight.

PBS listing

AMGEVITA injection 20 mg in 0.4 mL pre-filled syringe is listed on the PBS with 23 items, restricted by authority required streamlined, with an ex-manufacturer price of A$272.84.

Regulatory history

AMGEVITA was first registered on the ARTG on 9 November 2017 with multiple presentations including 40 mg/0.8 mL and 20 mg/0.4 mL pre-filled syringes and 40 mg/0.8 mL pre-filled pen. AMGEVITA, a biosimilar medicine containing adalimumab, was approved for registration on the Australian Register of Therapeutic Goods on 18 October 2017, covering all proposed indications mirroring those of its reference product, Humira. In November 2017, PBAC recommended AMGEVITA as a biosimilar brand for severe active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic plaque psoriasis, juvenile idiopathic arthritis, hidradenitis suppurativa, and uveitis. In December 2024, PBAC recommended listing for a General Schedule Authority Required formulation as a biosimilar brand of Humira, cost-minimised to the lowest cost PBS-listed adalimumab brand.