It has been announced that the US’ CSV Caremark, a CVS Health company and one of the country’s largest pharmacy benefit managers (PBMs), will remove AbbVie’s Humira (adalimumab), from its major national commercial formularies effective 1 April 2024, in favour of biosimilar options. In Europe, Sandoz has launched its biosimilar Hyrimoz (adalimumab), a citrate-free high-concentration formulation (HCF) indicated for all conditions of the reference medicine.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [1].
Regarding the CSV removal of Humira, the PBM noted that patients with Choice and Standard Opt Out commercial formulary coverage will still have the option to be treated with originator Humira. It is hoped that this move will save CSV customers more than 50% on adalimumab in 2024, compared to 2022 when there were no adalimumab biosimilars available in the US [1].
Sandoz’s biosimilar Hyrimoz HCF (adalimumab; adalimumab-adaz in the US) was approved in Europe and the US in March 2023 [2] and has been available in European markets since 21 November and July 2023, respectively. Biosimilar Hyrimoz citrate-free HCF is an updated formulation (100 mg/mL) to the currently available Hyrimoz 50 mg/mL and offers a 50 per cent reduction in injection volume, thereby potentially decreasing the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is administered with the Hyrimoz SensoReady pen for better patient experience.
CVS Caremark has entered into an agreement with AbbVie to supply Cordavis with a committed volume of co-branded originator Humira, which will be available in the second quarter of 2024.
Cordavis is a wholly-owned subsidiary and the biosimilar arm of CVS Health. It can collaborate directly with manufacturers to commercialize and co-produce biosimilar medicines for the US market [3].
Back in August 2023, Cordavis announced an agreement with Sandoz to commercialize and launch its biosimilar, Hyrimoz (adalimumab-adaz), under a Cordavis private label in the first quarter of 2024. It is priced more than 80% lower than Humira’s list price [3].
Both Hyrimoz and another unbranded Humira version from Sandoz will be covered across all CVS formularies, while branded and unbranded versions from India’s Biocon will be covered on some reimbursement lists.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from:
www.gabionline.net/biosimilars/news/us-and-ec-approvals-for-hyrimoz-us-approval-for-udenyca-autoinjector
3. GaBI Online - Generics and Biosimilars Initiative. CVS’ Cordavis to launch Sandoz’s Hyrimoz (adalimumab) [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 30]. Available from: www.gabionline.net/biosimilars/general/cvs-cordavis-to-launch-sandoz-s-hyrimoz-adalimumab
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