HADLIMA

What it is

Hadlima is a biosimilar medicine to Humira (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). Hadlima is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, pre-filled syringe, or as a single-use, auto-injector (Hadlima PushTouch).

Approved indications

— Reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis, including the 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 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 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, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients 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 who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy. — Treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients 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 Hadlima for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose. The recommended dose of Hadlima for patients with psoriatic arthritis is 40 mg adalimumab administered fortnightly as a single dose. The recommended dose of Hadlima for patients with ankylosing spondylitis is 40 mg adalimumab administered every fortnight as a single dose. The recommended Hadlima dose regimen for adult patients with Crohn's disease is: induction 160 mg initial dose (Day 0) as four 40 mg injections in one day OR as two 40 mg injections per day for two consecutive days, 80 mg second dose (Day 14) as two 40 mg injections, and maintenance 40 mg starting Day 28 and continuing fortnightly. The recommended dose of Hadlima for adult patients with psoriasis is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg fortnightly, starting one week after the initial dose. The recommended dose of Hadlima for adult patients with uveitis is an initial dose of 80 mg (given as two 40 mg injections), followed by 40 mg fortnightly, starting one week after the initial dose.

Key safety warnings

Serious infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving TNF-blocking agents including adalimumab. Sepsis, rare cases of tuberculosis and candidiasis have also been reported. Other serious infections include pneumonia, pyelonephritis, septic arthritis and septicaemia. Treatment with adalimumab should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. Patients should be monitored closely for infections – including tuberculosis before, during and after treatment with Hadlima. Use of TNF blockers, including adalimumab, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Patients at risk for HBV infection should be evaluated for evidence of prior HBV infection before initiating TNF blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Tuberculosis including reactivation and new onset of tuberculosis has been reported in patients receiving adalimumab. Reports included cases of pulmonary and extrapulmonary (disseminated). Before initiation of therapy with adalimumab, all patients should be evaluated for both active and inactive (latent) tuberculosis infection. 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 Barre syndrome. Prescribers should exercise caution in considering the use of Hadlima in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. In a clinical trial with another TNF antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed. Cases of worsening congestive heart failure have been reported in patients receiving adalimumab.

Contraindications

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

PBS listing

Hadlima 40 mg in 0.8 mL pre-filled syringe is listed on the PBS with 51 items, authority required restriction, and an ex-manufacturer price of A$444.17.

Regulatory history

Hadlima was first registered on the ARTG on 24 January 2018, with registration of both the 40 mg pre-filled syringe and 40 mg PushTouch auto-injector formulations. Additional ARTG registrations for a 40 mg/0.4 mL solution for injection in both pre-filled syringe and PushTouch auto-injector were listed on 15 February 2023.