Starting a biologic for the first time – are biosimilars truly ‘similar’?

What is it about?

Etanercept is one of the main treatment options for patients with rheumatoid arthritis (RA). In 2015, the patent for the original etanercept drug expired in Europe and consequently other pharmaceutical companies were able to make the drug; known as biosimilar. Biosimilar therapies must demonstrate the same clinical efficacy in clinical trials, and as a result, the NHS set guideline for at least 90% of new patients to be prescribed the biosimilar product by 2019. This analysis was done to compare etanercept originator (the original) with the etanercept biosimilar in adults with RA starting a biologic therapy for the first time in routine clinical practice in the UK. This analysis included 1806 adults with RA from the British Society for Rheumatology Biologics Register for RA (BSRBR-RA) study starting a biologic therapy for the first-time. In the 1009 starting etanercept originator and the 797 starting etanercept biosimilar, 30% achieved remission after six and 12 months of treatment, with no difference found between the two treatments. We found that one-in-five patients on the originator product were switched onto the biosimilar product, likely due to hospital policy (i.e. cost-saving). With most patients, three out of four, of either the originator or biosimilar still successfully on treatment after one year.

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Photo by Nappy on Unsplash

Photo by Nappy on Unsplash

Why is it important?

This is one of the largest analyses of adults with RA comparing those starting etanercept originator with those starting etanercept biosimilar. Using real-world data, we have shown that adults had similar improvements in their arthritis regardless of which product they are treated with. This is reassuring to patients and the clinical team when a patient with RA needs to start an etanercept therapy as their first biologic; either original or biosimilar.