Biosimilar medicines

Definition of a biosimilar medicine

A biosimilar medicine is a biological medicine which has been shown not to have any clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy.  Where NICE has already recommended the originator biological medicine, the same guidance will normally apply to a biosimilar of that originator. ​

In an era of significant economic, demographic and technological challenge it is crucial that patients get the best quality outcomes from medicines. Biological medicines in particular have revolutionised patient treatment by offering new and effective medicines for acute and chronic conditions including neutropenia, cancer, a wide range of inflammatory and autoimmune diseases, and enzyme or hormone deficiencies.

Biological medicines are currently the largest cost and cost growth areas in the NHS medicines budget. Using a new commissioning framework, NHS England aims to drive a step change in the uptake of biosimilar medicines by integrated care systems (ICS), who commission hospital trusts to provide the treatment, and make sure patients are offered the choice of switching to a new product by their specialist hospital doctor.

Through making biosimilar medicines more quickly available the NHS will be able to take advantage of up to £300m of savings each year offered by these new products, enabling more patients to have access to other life-saving and life-enhancing treatments.

Competition between different biological medicines, including biosimilar medicines, creates increased choice for patients and clinicians, and enhanced value propositions for individual medicines.  This is particularly relevant in the context of Future Focused Finance and the Right Care programme which is looking at how the NHS can be supported to take value based decisions. This approach also aligns with the principles of Medicines Optimisation and with initiatives focused on greater efficiency and productivity, such as the Carter Review.

NHS England is supporting the increased uptake of biosimilar medicines though the launch of its Top 10 Medicines Dashboard in July 2017. This follows from the Recommendations of Lord Carter’s 2016 report and is linked to the Model Hospital where the majority of NHS acute trusts will be able to review their potential savings opportunities for an initial group of 10 drugs, three of which are biosimilar products.

On 8 November 2022 the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of biosimilar products, which states that “Once authorised, a biosimilar product is considered to be interchangeable with their reference product (RP), which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect. Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP”. The guidance further explains that “as a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice”.

Making the most of biosimilars in our healthcare systems requires investment: investment in education around biosimilars, investment in experience and use, investment in establishing sustainable and appropriate procurement, and investment in transparent and clear decision-making frameworks.

NHS England has published a “What is a biosimilar medicine?” guide, which is an informative, non-prescriptive consensus document that provides key information on biosimilar medicines. The document is intended to provide an update for clinical and non-clinical stakeholders about the developing role of biosimilar medicines in the NHS in England and to support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to the benefit of patients.