Adalimumab patent expired, biosimilars now available

The patent for adalimumab, brand name Humira® has expired. New biosimilar versions of the drug are now available.

As you may have seen in the news, the patent for adalimumab, brand name Humira®, has expired. New biosimilar versions of the drug are now available.

If you are currently being prescribed adalimumab, your clinical team should work closely with you to discuss how this could impact your ongoing treatment and to alleviate any concerns you may have. If this does not happen, please be sure to approach your team directly with your questions.

Biosimilar medicines represent good value for the NHS since they are often much less costly than the originator medicine. They are thoroughly tested and analysed in the laboratory and in clinical trials to ensure they are as safe and effective as the originator biological medicine. They have also gained the regulatory approvals from and have been licenced by the authorities in the UK and Europe in the same way as all medicines. Biosimilars are only available on the NHS once the European Medicines Agency has looked at the evidence and decided that they are just as safe and effective as the original medicine.

Steve Brown, regional pharmacist for NHS England and NHS Improvement, is confident that biosimilars are safe. He says “there have been a number of research studies looking at how well biosimilars work and their safety. There appear to be no significant differences in efficacy between the originator biologicals and the new biosimilars.” He adds, “where patients switch to a biosimilar we expect them to remain stable, as if they had stayed on the originator biological medicine.”

NASS joined representatives from NRAS, Crohn’s & Colitis UK and the Psoriasis Association to issue the following statement:

“We welcome increased availability of effective treatment options for patients and understand the importance of the wise and careful use of NHS resources. Our organisations have been working in the field of biosimilars to provide patient information and support since 2014 and are familiar with the evidence to date which reinforces the fact that biosimilars are as safe and effective as the reference products. The introduction of biosimilars for adalimumab brings opportunities for both patients and the NHS. However, it is vital that patients are fully informed about all the treatment options available to them and commissioners and health professionals adopt the principles of shared decision-making. At a time when services are thinking about new contracts, we would also hope that patients’ views are proactively sought and that things that matter to patients, including excipients, device and homecare packages, are given due consideration.”

NASS is committed to supporting the principles of shared decision-making, and to ensuring that the views and requirements of people with axial spondyloarthritis (axial SpA) including ankylosing spondylitis (AS) are sought after and taken into consideration at all times with regard to any new development which impacts our community. We will be sharing all new information as it is forthcoming, but should you have any questions in the interim, please contact your clinical team or our helpline on 020 8741 1515.

Download NHS FAQs on adalimumab biosimilar

 

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