Adalimumab biosimilars launched in the EU

Four new adalimumab biosimilar medicines have recently been launched in the EU. Amgevita (Amgen), Imraldi (Biogen), Hyrimoz (Sandoz) and Hulio (Mylan) are all biosimilars referencing AbbVie’s Humira, which went off patent in October.

Adalimumab is a monoclonal antibody targeting tumour necrosis factor (TNF) alpha. It is an immunosuppressant indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. It is usually used when the condition is moderately severe or severe, or when other treatments cannot be used. It is administered as a subcutaneous injection usually every two weeks, depending on the indication being treated. The most common side-effects are infections, injection-site reactions, headache, and muscle and bone pain.

Adalimumab is currently the most commonly prescribed biological medicine. According to NHS England, it is the single medicine on which the NHS spends the most, with an annual cost of more than £400 million in 2017/18. Over 46,000 patients are prescribed the Humira brand of adalimumab, and NHS England hopes that the availability of new biosimilar options will result in savings of up to £150 million a year by 2021.

NHS England has issued guidance to Trusts and CCGs asking them to start nine out of 10 new patients on the best value medicine within three months of a biosimilar launch. In addition, at least 80% of existing patients should be switched to the best value medicine within 12 months of launch.

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