Novartis subsidiary Sandoz has made available a citrate-free, high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) injection, a biosimilar of Humira (adalimumab), in the United States (US).
The treatment is indicated for usage in areas that are not covered by the reference medicine Humira’s regulatory exclusivity.
The indications include inflammatory ailments namely juvenile idiopathic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, plaque psoriasis, Crohn’s disease and hidradenitis suppurativa.
Compared to the 50mg/mL dosing, Hyrimoz HCF is claimed to provide a decrease of 50% in injection volume as well as less number of injections needed for individuals who require a minimum of 80mg/0.8 mL dosage.
A tumour necrosis factor (TNF) inhibitor, Hyrimoz acts by hindering the protein that causes symptoms of autoimmune diseases.
The HCF formulation is administered using a prefilled auto-injector, Sensoready pen, which enables usage by oneself.
Sandoz has set up a patient support programme, Sandoz One Source for Hyrimoz, through which support for reimbursement, education and affordability is provided.
Sandoz North America president Keren Haruvi said: “With this launch, we are entering the US immunology market and continuing to fulfil our commitment to expand access to important medicines for patients.”
“Sandoz has a long history of developing and marketing biosimilars that generate healthcare savings and enhance competition that drives innovation in the market.”