HYRIMOZ

What it is

HYRIMOZ (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. HYRIMOZ is a biosimilar medicine to HUMIRA®. HYRIMOZ is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration.

Approved indications

— Reducing signs and symptoms and inhibiting progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis, including recently diagnosed disease, used alone or in combination with methotrexate. — Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older with inadequate response to one or more DMARDs, in combination with methotrexate or as monotherapy. — Treatment of enthesitis-related arthritis in children with inadequate response to or intolerance to conventional therapy. — Treatment of signs and symptoms and inhibiting progression of structural damage of moderate to severely active psoriatic arthritis in adult patients with inadequate response to previous DMARDs. — Reducing signs and symptoms in patients with active ankylosing spondylitis. — Treatment of moderate to severe Crohn's disease in patients 6 years and older with inadequate response to conventional therapies or loss of response to or intolerance to infliximab. — Treatment of moderate to severe ulcerative colitis in adult patients with inadequate response to conventional therapy or intolerance to or contraindications for such therapies. — Treatment of moderate to severe chronic plaque psoriasis in adult patients, and severe chronic plaque psoriasis in children and adolescents from 4 years of age with inadequate response to or who are inappropriate candidates for topical therapy and phototherapy. — Treatment of active moderate to severe hidradenitis suppurativa in patients with inadequate response to conventional systemic therapy. — Treatment of 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 of HYRIMOZ 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 HYRIMOZ to 40 mg every week or 80 mg fortnightly. For psoriatic arthritis, the recommended dose is 40 mg adalimumab administered fortnightly as a single dose. For ankylosing spondylitis, the recommended dose 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 weight: 20 mg fortnightly for patients 10 kg to less than 30 kg, and 40 mg fortnightly for patients 30 kg and over.

Key safety warnings

The comparability of HYRIMOZ with HUMIRA has been demonstrated with regard to physicochemical characteristics and efficacy and safety outcomes.

PBS listing

HYRIMOZ 40 mg in 0.8 mL pre-filled pen is listed on the PBS with 55 items under authority-required restriction at an ex-manufacturer price of A$444.17.

Regulatory history

HYRIMOZ adalimumab 40 mg solution for injection was first registered on the ARTG on 1 March 2019 in both pre-filled syringe and pre-filled pen formulations. In July 2018, the PBAC recommended listing of the biosimilar brand for severe active rheumatoid arthritis. In March 2020, the PBAC recommended listing for Crohn disease, ulcerative colitis, juvenile idiopathic arthritis, fistulising Crohn disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis, and hidradenitis suppurativa. Additional ARTG registrations for 80 mg, 40 mg/0.4 mL, and 20 mg/0.2 mL presentations were added on 15 May 2024.