ABRILADA

What it is

ABRILADA is a biosimilar medicine to HUMIRA containing adalimumab. Adalimumab is a tumour necrosis factor (TNF) blocker. Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. ABRILADA is supplied as a solution for injection that is clear, colourless to very light brown. It is available in 20 mg and 40 mg formulations in pre-filled syringes, pre-filled pens, and vials.

Approved indications

— Reducing signs and symptoms and inhibiting progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis, including patients with recently diagnosed disease who have not received methotrexate. — Reducing 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 (DMARDs), in combination with methotrexate. — Treatment of enthesitis-related arthritis in children who have had an inadequate response to or are intolerant to conventional therapy. — Treatment of signs and symptoms and inhibiting 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 in patients 6 years and older to reduce signs and symptoms and induce and maintain clinical remission in those who have had 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 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 inadequate response to or are inappropriate candidates for topical therapy and phototherapy. — Treatment of active moderate to severe hidradenitis suppurativa in patients from 12 years of age who have inadequate response to conventional systemic therapy. — Treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Dosing overview

The recommended dose of ABRILADA 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 to 40 mg every week, or 80 mg fortnightly. The recommended dose for patients with psoriatic arthritis is 40 mg administered fortnightly as a single dose. For ankylosing spondylitis, the recommended dose is 40 mg administered fortnightly 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 weight: 20 mg fortnightly for patients weighing 10 kg to less than 30 kg, and 40 mg fortnightly for patients weighing 30 kg or more. ABRILADA is administered by subcutaneous injection. Patients may self-inject after proper training in subcutaneous injection technique, with injection sites including the thigh or abdomen.

Key safety warnings

For ulcerative colitis, patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.

PBS listing

Information regarding PBS listing, strength, restriction type, and ex-manufacturer price is not available in the provided documents.

Regulatory history

ABRILADA was first listed on the ARTG on 22 February 2021 in four formulations: 20 mg pre-filled syringe, 40 mg pre-filled pen, 40 mg pre-filled syringe, and 40 mg vial. The PBAC recommended ABRILADA in July 2021 for Crohn disease, ulcerative colitis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and hidradenitis suppurativa.