Guidance

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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 2 November 2015

Documents

What is a Biosimilar Medicine?

http://www.england.nhs.uk/ourwork/pe/mo-dash/#biosimilars

Details

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