YUFLYMA

What it is

Yuflyma is a biosimilar medicine to Humira (adalimumab). Yuflyma is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. Yuflyma is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration.

Approved indications

— Rheumatoid arthritis: reducing signs and symptoms, and inhibiting progression of structural damage in adult patients with moderate to severely active disease, including recently diagnosed disease without prior methotrexate; can be used alone or in combination with methotrexate. — Polyarticular juvenile idiopathic arthritis: in combination with methotrexate for moderately to severely active disease in patients 2 years of age and older with inadequate response to one or more DMARDs; can be given as monotherapy in case of methotrexate intolerance or when continued methotrexate is inappropriate. — Enthesitis-related arthritis: treatment in children with inadequate response to, or intolerance of, conventional therapy. — Psoriatic arthritis: treatment of signs and symptoms, and inhibiting progression of structural damage, in moderate to severely active disease in adult patients with inadequate response to previous DMARDs. — Ankylosing spondylitis: reducing signs and symptoms in patients with active disease. — Crohn's disease in adults and children 6 years and over: treatment of moderate to severe disease to reduce signs and symptoms and induce and maintain clinical remission in patients with inadequate response to conventional therapies, or those who have lost response to or are intolerant to infliximab. — Ulcerative colitis: treatment of moderate to severe disease in adult patients with inadequate response to conventional therapy or intolerance to or medical contraindications for such therapies. — Psoriasis: 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 adolescents from 4 years of age with inadequate response to or who are inappropriate candidates for topical therapy and phototherapy. — Hidradenitis suppurativa: treatment of active moderate to severe disease in patients 12 years of age and older with inadequate response to conventional systemic therapy. — Uveitis: treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients with inadequate response to corticosteroids, in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Dosing overview

For rheumatoid arthritis, the recommended dose 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 juvenile idiopathic arthritis in patients 2 years of age and older, dosing is weight-based: 10 kg to less than 30 kg receive 20 mg fortnightly; 30 kg or more receive 40 mg fortnightly. For psoriatic arthritis, the recommended dose is 40 mg fortnightly as a single dose. For ankylosing spondylitis, the recommended dose is 40 mg fortnightly as a single dose. For Crohn's disease in adults, induction is 160 mg initially, followed by 80 mg at day 14, then 40 mg fortnightly for maintenance. For ulcerative colitis in adults, induction is 160 mg initially, followed by 80 mg at day 14, then 40 mg fortnightly for maintenance. For psoriasis in adults, the initial dose is 80 mg, followed by 40 mg fortnightly starting one week later.

Key safety warnings

Serious infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic and opportunistic infections have been reported in patients receiving TNF-blocking agents, including adalimumab. These include sepsis, tuberculosis, candidiasis, pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported. TNF blockers, including adalimumab, have been associated with reactivation of hepatitis B virus in patients who are chronic carriers, and in some instances this reactivation has been fatal. Patients at risk for hepatitis B infection should be evaluated for evidence of prior infection before initiating TNF blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as hepatitis B virus carriers, and these patients should be closely monitored for signs and symptoms of active hepatitis B infection throughout and for several months after therapy. Tuberculosis, including reactivation and new onset, has been reported in patients receiving adalimumab, with cases of both pulmonary and extrapulmonary disease. All patients should be evaluated for both active and inactive tuberculosis before initiating therapy, with appropriate screening tests performed in accordance with local recommendations, and treatment of latent tuberculosis should be initiated prior to adalimumab therapy. Adalimumab has been associated in rare cases with new onset or exacerbation of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease including Guillain Barré syndrome. Prescribers should exercise caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders, and discontinuation should be considered if these disorders develop. Worsening congestive heart failure and increased mortality due to congestive heart failure have been observed with TNF antagonists. 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 and is contraindicated in moderate or severe heart failure.

Contraindications

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

PBS listing

Yuflyma is listed on the PBS in multiple presentations. The 80 mg in 0.8 mL pre-filled syringe is listed as 1 item with streamlined restriction at an ex-manufacturer price of A$618.90. The 40 mg in 0.4 mL pre-filled pen is listed as 11 items with streamlined and authority required restrictions at A$444.17. The 40 mg in 0.4 mL pre-filled syringe is listed as 10 items with streamlined and authority required restrictions at A$444.17. The 80 mg in 0.8 mL pre-filled pen is listed as 1 item with streamlined restriction at A$618.90.

Regulatory history

Yuflyma was approved by the TGA on 28 February 2022 as a new biosimilar medicine. The approval was based on demonstrated biosimilarity to the innovator medicine Humira across a range of inflammatory conditions. The 40 mg pre-filled syringe presentations were first listed on the ARTG on 25 March 2022, with the 80 mg pre-filled syringe and pen presentations listed on 30 June 2023, and the 20 mg pre-filled syringe listed on 26 September 2024. The PBAC recommended Yuflyma in July 2022 for severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, and moderate to severe hidradenitis suppurativa.