NHS England updates its ‘What is a Biosimilar Medicine?’

Biosimilars/General | Posted 02/08/2019 post-comment0 Post your comment

The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.


The NHS document provides an update for key clinical and non-clinical stakeholders about the role of biosimilars in the NHS in England. It also aims to support the safe, effective and consistent use of all biological medicines, including biosimilars, to the benefit of patients.

The document was produced in collaboration with a whole host of associations and agencies, including the Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association (BIA), British Biosimilars Association (BBA), Medicines and Healthcare products Regulatory Agency (MHRA), The National Institute for Health and Care Excellence (NICE), Royal Pharmaceutical Society (RPS), National Rheumatoid Arthritis Society (NRAS), and the NHS England Biosimilars Programme Board.

There are currently 15 originator biologicals with approved biosimilars available for use in the UK, as well as many in development. The NHS therefore estimates that, ‘as the biosimilar market develops, increased competition between biologicals has the potential to deliver significant savings to the NHS of at least GBP 400–500 million per year by 2020/21 through increased uptake of the best value biological medicines, including biosimilars’.

Key messages in the document include, among others, that:
• Biosimilars are considered to be highly similar and therapeutically equivalent to the reference biological. As a result, the prescriber can switch a patient from the reference biological to its biosimilar.
• The decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar medicine (or to change between the two), rests with the responsible prescriber in consultation with the patient; in line with the principles of shared decision-making. This should be in accordance with the approved indications on the summary of product characteristics (SmPC) and ideally be part of a biological medicines review.
• Biologicals, including biosimilars, should be prescribed by their brand name and not by the international nonproprietary name (INN), in line with MHRA guidelines and to support ongoing pharmacovigilance.

This document is just the latest of a number of initiatives by NHS England. In September 2017, NHS England released a ‘Commissioning framework for biological medicines (including biosimilars) with the aim of increasing both biological and biosimilar uptake [1].

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1. GaBI Online - Generics and Biosimilars Initiative. NHS England to increase biosimilar usage [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Biosimilars/General/NHS-England-to-increase-biosimilar-usage 

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Source: NHS England

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