The NHS is bringing a new generation of biosimilar medicines to patients, providing greater access to key treatments for thousands of patients. This guide provides key information for key clinical and non-clinical stakeholders about the role of biosimilar medicines in the NHS in England to support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to the benefit of patients.
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”.
Any decision to move to a biosimilar medicine should first be made based on clinical judgement for individual patients and secondly, on the basis of the overall value proposition offered by individual medicines. It is important to consider appropriate engagement with key stakeholders, local implementation plans and timelines alongside monitoring and data collection.
