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 one of the largest cost and cost growth areas in the NHS medicines budget. Using the updated  commissioning framework, NHS England aims to accelerate and widen the adoption of best value biological medicines across the NHS. The revised framework builds on previous work to support integrated care boards (ICBs) and providers to act promptly to secure savings opportunities as more competitive biosimilars enter the market, and emphasises the importance of taking a collaborative approach from the outset.

Biosimilars are typically substantially less expensive than their reference product, and the increased competition that they bring to the biological medicines market creates increased access and choice for patients and clinicians, without compromising outcomes and patient care.

The MHRA has now updated guidance on the licensing of biosimilar products for interchangeability: “Once authorised, a biosimilar product is considered to be interchangeable with their reference product, which means a prescriber can choose the biosimilar over the reference product (or vice versa) and expect to achieve the same therapeutic effect. A biosimilar product is also considered to be interchangeable with another biosimilar to the same reference product”. The guidance further explains that “as a result of interchangeability, switching patients from one product to another (reference product or biosimilar) has become an acceptable clinical practice”.

Through making biosimilar medicines more quickly available, the NHS will be able to take advantage of significant savings, enabling many more patients benefit from reinvestment in services and improved access to new and innovative therapies.

NHS England is supporting the increased uptake of biosimilar medicines by identifying nationally prioritised biological medicines for switching, and working with the systems to develop a national programme of work.

In addition, 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.