Sandoz Brings Its Fifth Biosimilar To Market In The UK With Hyrimoz? (Adalimumab), Offering Potential Savings Of More Than £250M Per Year

• Hyrimoz is the Sandoz biosimilar of Humira, the biggest driver of NHS spending in the UK at more than £500M per year
• Today marks the patent expiry of Humira, unlocking the opportunity for a better value adalimumab biosimilars such as Hyrimoz to create considerable savings for the NHS
• Hyrimoz could lead to potential savings of £250M per year
• It is the fifth Sandoz biosimilar available for use in the UK, further demonstrating the Sandoz commitment to making access happen

Sandoz, a Novartis division, recently announced that Hyrimoz (adalimumab) is available for patients in the UK. Hyrimoz is a biosimilar medicine and has been approved for use in all the indications of its reference biologic medicine, Humira. These include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and uveitis.

Kavya Gopal, Head of Speciality at Sandoz UK said: “The NHS currently spends over £500M a year on Humira alone – the reference adalimumab. Now that doctors can prescribe Hyrimoz, Sandoz biosimilar adalimumab, the NHS has the opportunity to increase patient access to biologic treatments. As we’ve worked to launch Hyrimoz as the Humira patent expires, the NHS can start saving money from today.”

The NHS Specialist Pharmacy Service has developed resources to support the adoption of biosimilar adalimumab, having recently developed the Biosimilar Adalimumab Toolkit for commissioners and providers, as well as draft materials for physicians to use with their patients, to support those moving onto a biosimilar. With a drive by NHS England to see trusts use these medicines on at least 80% of patients within 12 months, it is now important for the NHS to embed the principles of switching to the best value biological medicine into commissioning and clinical practice, in order to realise the maximum savings associated with these medicines.

Adalimumab is currently administered to 57,000 people in England via a homecare supply route. With so many people potentially impacted, continued supply of this medicine is essential. As such, Sandoz has undertaken a stockbuild to ensure supply of Hyrimoz (adalimumab) to the NHS should there be a ‘no deal’ scenario in the Brexit negotiations. The approval of Hyrimoz was based on the review of a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matched the reference medicine in terms of safety, efficacy and quality.

The randomised, double-blind, three-arm, parallel study met its primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic. No meaningful clinical differences were observed.

About Sandoz
Sandoz is the pioneer and a global leader in biosimilars, with additional biosimilars for oncology and immunology indications expected to launch globally by 2020. As a Novartis division, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialisation.