Rheumatologists want to see system in place to track efficacy and safety of biosimilar products

The BSR’s registers track responses to biologics, including biosimilars, used to treat rheumatoid arthritis and ankylosing spondylitis.

The British Society of Rheumatology (BSR) is creating its own evidence database to track the efficacy and long-term safety of new biosimilar products coming on to the UK market.

The British Society of Rheumatology (BSR) is calling for clinicians to register patients with its biologics registers to track the efficacy and long-term safety of new biosimilar products coming on to the UK market.

The BSR – the professional association for health professionals involved in rheumatology and muscular skeletal disease – maintains two biologics patient registers. One is for people being treated for rheumatoid arthritis, the other for patients with ankylosing spondylitis.

The BSR has released a position statement on biosimilars and says that it supports their introduction but wants to make sure that a system is in place to monitor their safety and efficacy in order to reassure health professionals and the public.

“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,” says Alex MacGregor, chair of BSR Biologics Registers.

“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.”

The release of the BSR’s position statement comes as biosimilar versions of Janssen Biologics’s Remicade — a medicine that contains the monoclonal antibody infliximab and is used for a variety of inflammatory conditions including rheumatoid arthritis — are being launched in the UK by Napp Pharmaceuticals and Hospira after patent protection for the innovator product ceased on 24 February 2015. 

 

  • This article was amended on 5 March 2015 to clarify that the British Society of Rheumatology’s biologics registers are not new. 
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Citation
The Pharmaceutical Journal, PJ, 7 March 2015, Vol 294, No 7852;294(7852):DOI:10.1211/PJ.2015.20068032