UK outlines process for developing biosimilars guidances

Home/Policies & Legislation | Posted 23/01/2015 post-comment0 Post your comment

In response to the increasing availability and use of biosimilars by the UK’s National Health Service (NHS), the country’s healthcare watchdog, the National Institute for Health and Care Excellence (NICE), has updated its methods for providing guidance and advice on biosimilars.

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

In its 6 January 2015 position statement NICE states that it will consider biosimilars in the context of a multiple technology appraisal in parallel with their reference products in the indication under consideration. Positive appraisals of biosimilars will use the name of the active drug substance, including the reference product and brand name, to inform clinical decisions.

NICE technology appraisals assess the clinical and cost-effectiveness of drugs and provide recommendations to the NHS.

The decision by NICE to use the name of the active drug substance aligns with the majority of European Union Member States, which have agreed that biosimilars should have the same International Nonproprietary Name (INN) as their reference biological [1].

In other circumstances, when NICE does not make a recommendation and where the agency considers a review of the evidence for a biosimilar necessary, NICE will consider producing an ‘evidence summary new medicine’. Evidence summaries will use the brand names of the medicines because substitutability and interchangeability cannot be assumed.

NICE believes that ‘biosimilars have the potential to offer the NHS considerable cost savings, especially as they are often used to treat long-term conditions’. This statement is in agreement with the European Commission, which believes that ‘increasing uptake of biosimilars can contribute to the success of the dual objectives of improving overall public health and the sustainability of Member States’ healthcare systems’ [2].

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1.   GaBI Online - Generics and Biosimilars Initiative. EU majority says same INNs for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: 
2.   GaBI Online - Generics and Biosimilars Initiative. Generics and biosimilars contribute to European drug savings []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from:

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Source: NICE

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