Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what guidance the NHS has given on the minimum standards for consenting patients when their originator biological medicine is switched for a biosimilar.

We have had no such discussions with patient groups.

NHS England published the guide What is a biosimilar medicine? in September 2015. This provides key information to clinical and non-clinical stakeholders on the developing role of biosimilar medicines in the NHS in England and support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to the benefit of patients.

The guide requires prescribers to explain to patients the likely benefits, risks and burdens, including serious and common side effects of treatments they are proposing. Sections 4.3 – 4.5 of the document provide guidance on patients being switched from their originator medicine to a biosimilar. The guide is available at:

www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf