Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.



This publication was developed in partnership with NHS England, the Medicines and Healthcare products Regulatory Agency (MHRA) and:

  • the Association of the British Pharmaceutical Industry
  • the BioIndustry Association
  • the British Generic Manufacturers Association
  • The National Institute for Health and Care Excellence
  • the Royal Pharmaceutical Society

This document includes:

  • key facts
  • considerations for the NHS
  • the licensing of biosimilar medicines
  • monitoring biological and biosimilar medicines
  • pharmacovigilance