Biosimilar Medicines

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.

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.

Although biosimilar medicines have been used in the NHS for many years, recently there has been an increase in the range of biosimilar medicines available. As the patent expires for individual originator/reference medicines, biosimilar medicines can be introduced. With additional biosimilar medicines in development or under review for approval, more and more NHS staff will be involved in prescribing, administering, supplying and monitoring these biosimilar medicines and many more patients will be eligible for treatment with a biosimilar medicine.

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. Given NHS England’s system leadership role, we are undertaking a programme of work to improve clinician confidence and clarify understanding amongst decision makers, such as commissioners, clinicians, pharmacists, patients and others in their consideration of the appropriate use of biosimilar medicines.

As a starting point, NHS England published on 24 September 2015, 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.

The guide was jointly developed by NHS England, MHRA, NICE, Royal Pharmaceutical Society and industry (ABPI, BIA and BGMA), and is the first collaborative national publication on the topic of biosimilar medicines.

NHS England is working alongside national delivery partners to progress a collaborative work programme at pace, to improve education and understanding of both the theory and practical considerations related to biosimilar medicines.  We are also working closely with NHS Clinical Commissioners, regional Medical Directors, and AHSN’s to maximise the opportunities of a more competitive biological medicines market for the benefit of patients.