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The British Society for Rheumatology supports the use of biosimilars but recommends measures to monitor safety

() has outlined its stance on biosimilars, a new kind of medicine that have the potential to extend the range of treatments available to patients, at a lower cost to taxpayers.

Whilst BSR welcomes their introduction, we also recommend that measures are in place to monitor their safety and efficacy in order to provide patients and health professionals with suitable assurances.

Biosimilar medicines are a manufactured to be similar to an existing licensed , with no meaningful differences from the reference medicine in terms of quality, safety or efficacy. The first biosimilars for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis will be introduced to the UK this month.

Although these drugs have undergone stringent testing before being authorised, there are still a few gaps in the evidence base on their safety and efficacy, which the BSR feels will need to be addressed.

As with any new medicine, there is a lack of knowledge on the long-term safety and it is vital that a consistent and systematic method is adopted to monitor the safety and effectiveness of biosimilars. The BSR supports rheumatologists to do this by providing the BSR Biologics Register. This mechanism is a way of collectively contributing to a substantial and important evidence base.

Details of applying for registration on the BSR Biologics register can be found at www.rheumatology.org.uk/resources/bsr_biologics_registers/about.aspx

Professor Alex MacGregor, Chair of BSR Biologics Registers states:

“Widening the range of treatments available to our patients at a lower cost to the NHS is clearly a positive step, but there are still a few gaps in the evidence for the safety and efficacy of these products, which will need to be explored further. For example, the clinical trials of these drugs for people of rheumatological or autoimmune diseases were with new users only, and no trials have explored the effects of substitution from a reference drug. This and other points are outlined in our position statement. We urge our members to be open and clear with patients about their choices in treatment and to focus on their clinical needs when prescribing.”

Professor MacGregor went on to underline “the need for more information for clinicians and patients on these emerging products and the importance of patients registering with the BSR Biologics register, when starting or switching to biosimilars. This would provide the same systematic collection of data on adverse effects that is currently being undertaken for the existing reference medicines, allowing clinicians and patients to make informed choices about treatment options.”

The full set of BSR recommendations, designed to address the uncertainty created by the introduction of these biological medicines, can be found on the BSR website. In developing these recommendations we have consulted widely with a range of groups with an interest in biosimilars, including NRAS, NICE, and ABPI.


Source: British Society for Rheumatology (BSR)