What is a biosimilar medicine?

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


What is a Biosimilar Medicine?


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
Published 2 November 2015