Biosimilars in UK gain NICE recommendation Posted 05/02/2016

Biosimilars may be set to increase their market share in the UK after the country’s healthcare cost watchdog recommended that rheumatoid arthritis patients indicated for treatment with biologicals should ‘start treatment with the least expensive drug’.

The UK’s National Institute for Health and Care Excellence (NICE) published the guidance on 26 January 2016. The guidance covers seven different biologicals: abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab and tocilizumab.

NICE is an independent organization, set up by the UK Government in 1999. The agency decides which drugs and treatments are available on the National Health System (NHS) in England and Wales.

Two infliximab biosimilars, Remsima from Napp Pharmaceuticals and Inflectra from Hospira UK, have been approved for marketing in the UK and are included in the guidance. The NICE recommendation will clearly lead to increased use of these biosimilars due to their lower price compared to the originator infliximab, Johnson & Johnson’s Remicade. A 100-mg vial of Remicade costs GBP 419.62, whereas the list price of a 100-mg vial of Remsima and Inflectra is only GBP 377.66. The NHS has also managed to negotiate lower prices for the biosimilars, although the exact numbers remain confidential. The biosimilars also cost less on an annual basis than the cost of the originators for the other six biologicals.

More arthritis biosimilars may also soon be hitting the UK market. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of the biosimilar etanercept Benepali (SB4) in November 2015 [1]. In December 2015, the agency accepted an application from Sandoz, the generics division of Novartis, for its etanercept biosimilar (GP2015) [2].

NICE estimates that there are around 400,000 people with rheumatoid arthritis in the UK, with approximately 15% of these having severe disease.

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UK patient groups say pharma needs to reduce cost of medicines

1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. Available from:  
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. Available from:  

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Source: NICE

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