CIPTUNEC

What it is

CIPTUNEC is adalimumab, a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. CIPTUNEC is a biosimilar medicine to HUMIRA. It is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration.

Approved indications

— Reducing signs and symptoms, and inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis, including recently diagnosed disease in patients 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 DMARDs. — 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 in patients aged 6 years and older, to reduce signs and symptoms and induce and maintain clinical remission in those with 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 in patients aged 12 years and older 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.

Dosing overview

The recommended dose of CIPTUNEC 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. For patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis, dosing is based on weight: 20 mg fortnightly for those 10 kg to less than 30 kg, and 40 mg fortnightly for those 30 kg or greater. For psoriatic arthritis, the recommended dose is 40 mg administered fortnightly. For ankylosing spondylitis, the recommended dose is 40 mg administered every fortnight.

Regulatory history

CIPTUNEC was approved for registration by the TGA on 23 August 2022. The approval was based on demonstrated comparability to Humira, supporting its use for a range of inflammatory conditions. ARTG registration for three presentations occurred on 6 September 2022: the 40 mg/0.4 mL pre-filled syringe (ARTG 373065), the 80 mg/0.8 mL pre-filled syringe (ARTG 374374), and the 40 mg/0.4 mL pre-filled pen (ARTG 374373).