NEPEXTO

What it is

NEPEXTO is a biosimilar medicine to Enbrel containing etanercept. Each NEPEXTO auto-injector contains 50 mg of etanercept and pre-filled syringe contains either 25 mg or 50 mg of etanercept. NEPEXTO solution for injection in the auto-injector and pre-filled syringe is a clear to opalescent, colourless to yellow solution.

Approved indications

— Active, adult rheumatoid arthritis in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs. — Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. — Signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. — Moderate to severe chronic plaque psoriasis in adult patients, who are candidates for phototherapy or systemic therapy. — Signs and symptoms of active ankylosing spondylitis in adults. — Active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation as indicated by elevated C-reactive protein and/or MRI change who have had an inadequate response to NSAIDs. — Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs. — Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. — Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. — Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. — Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Dosing overview

NEPEXTO should only be administered in children and adolescents weighing 62.5 kg or more. Elderly RA patients (age ≥ 65 years) show similar safety, efficacy and pharmacokinetic profiles compared to younger adult patients treated with NEPEXTO. Dose adjustment is not needed for the elderly.

Key safety warnings

Serious infections including sepsis and tuberculosis have been reported with the use of etanercept. Some of these infections have been fatal. These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). Opportunistic infections have also been reported (including listeriosis, legionellosis and invasive fungal infections) in patients receiving etanercept. Tuberculosis (including disseminated or extrapulmonary presentation) has been observed in patients receiving TNF-blocking agents, including etanercept. Tuberculosis may be due to reactivation of latent TB infection or to new infection. Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus has been reported. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Post-marketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis) have been received, some of which had fatal outcomes. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. Post-marketing reports of worsening of congestive heart failure have been received, with and without identifiable precipitating factors. There have also been rare reports of new onset congestive heart failure, including in patients without known pre-existing cardiovascular disease. Although no clinical trials have been performed evaluating etanercept therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity. Treatment with etanercept and other agents that inhibit TNF have been associated with rare cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability.

Contraindications

Known hypersensitivity to etanercept or to any of its excipients. Patients with, or at risk of, sepsis. Treatment with NEPEXTO should not be initiated in patients with serious, active infection including chronic or localised infections. Concurrent treatment with Interleukin-1 antagonists.

PBS listing

As of July 2025, NEPEXTO was recommended for severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, and juvenile idiopathic arthritis. It was recommended for listing as a biosimilar on a cost-minimisation basis under the same conditions as its reference biologic, Enbrel.

Regulatory history

NEPEXTO etanercept 25 mg in 0.5 mL solution for injection pre-filled syringe was first listed on the ARTG on 30 September 2020. NEPEXTO etanercept 50 mg in 1.0 mL solution for injection pre-filled syringe was first listed on the ARTG on 1 October 2020. NEPEXTO etanercept 50 mg/1 mL solution for injection auto-injector was first listed on the ARTG on 14 September 2022. In July 2025, the PBAC recommended NEPEXTO for listing on the PBS.