ADALICIP

What it is

Adalicip is a biosimilar medicine to Humira containing adalimumab. Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Adalimumab binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). The comparability of Adalicip with Humira has been demonstrated with regard to physicochemical characteristics and efficacy and safety outcomes. Adalicip 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 treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. — Reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing ≥30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs, in combination with methotrexate. — 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 disease modifying anti-rheumatic drugs has been inadequate. — Reducing signs and symptoms in patients with active ankylosing spondylitis. — Treatment of moderate to severe Crohn's disease to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients aged 6 years and older weighing ≥40 kg 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 weighing ≥40 kg 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 from 12 years of age 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 Adalicip 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 Adalicip to 40 mg every week, or 80 mg fortnightly. The recommended dose of Adalicip for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose. The recommended dose of Adalicip for patients with ankylosing spondylitis is 40 mg adalimumab administered every fortnight as a single dose. For indications requiring loading doses, such as Crohn's disease and ulcerative colitis, the recommended Adalicip dose regimen includes an induction phase with 160 mg initial dose (given in divided doses over one or two days), followed by 80 mg on Day 14, then maintenance therapy with 40 mg starting Day 28 and continuing fortnightly. For adult psoriasis, the recommended dose is an initial dose of 80 mg, followed by 40 mg fortnightly, starting one week after the initial dose. For uveitis in adults, the recommended dose is an initial dose of 80 mg, followed by 40 mg fortnightly, starting one week after the initial dose.

Key safety warnings

Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidioidomycosis), viral, parasitic or other opportunistic infections such as listeriosis, Legionellosis and pneumocystis have been reported in patients receiving adalimumab. Treatment with adalimumab should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. Tuberculosis including reactivation and new onset of tuberculosis has been reported in patients receiving adalimumab, with cases of both pulmonary and extrapulmonary (disseminated) disease, and all patients should be evaluated for both active and inactive (latent) tuberculosis infection before initiation of therapy. Use of TNF blockers, including adalimumab, has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of this virus, and in some instances has been fatal. Patients at risk for hepatitis B virus infection should be evaluated for evidence of prior hepatitis B virus infection before initiating TNF blocker therapy. Adalimumab has been associated in rare cases with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain Barré syndrome, and prescribers should exercise caution in considering the use of adalimumab in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. In controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving adalimumab compared with control patients, although the occurrence was rare. Very rare post marketing reports of hepatosplenic T-cell lymphoma, a rare aggressive lymphoma that is often fatal, have been identified in patients treated with adalimumab, with most patients having prior infliximab therapy as well as concomitant azathioprine or 6-mercaptopurine use. Cases of worsening congestive heart failure have been reported in patients receiving adalimumab, adalimumab should be used with caution in patients with mild heart failure (NYHA class I/II), and is contraindicated in moderate or severe heart failure.

Contraindications

Adalimumab should not be administered to patients with known hypersensitivity to adalimumab or any of its excipients. Adalimumab is contraindicated in severe infections including sepsis, active tuberculosis and opportunistic infections. Concurrent administration of adalimumab and anakinra (interleukin-1 receptor antagonist) is contraindicated. Moderate to severe heart failure (NYHA class III/IV) is a contraindication.

PBS listing

Information regarding the PBS listing details for Adalicip is not provided in the source documents.

Regulatory history

Adalicip was approved for registration by the TGA on 23 August 2022. ARTG registrations were listed on 6 September 2022 for three formulations: adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled pen, adalimumab 80 mg/0.8 mL solution for subcutaneous injection pre-filled syringe, and adalimumab 40 mg/0.4 mL solution for subcutaneous injection pre-filled syringe. The approval was based on demonstrated comparability to Humira, with the TGA evaluation finding that Adalicip demonstrated comparability with the reference product Humira across physicochemical characteristics, efficacy, and safety outcomes.