Biosimilar medicines

In this section of our website, you will find information about biosimilar medicines.

A biosimilar is a biological medicine that is very like another biological medicine (known as a reference medicine) which already has a marketing authorisation and has been approved for use in patients.

Biological and biosimilar medicines: What patients should know

The HPRA have published answers in plain English to a range of questions on biological and biosimilar medicines. This information should be particularly helpful if you, or someone in your care, has recently been prescribed a biological or biosimilar medicine.

HPRA guide to biosimilar medicines: Information for health professionals

This guidance document provides helpful information on the regulation, prescribing, dispensing and traceability of biosimilar medicines in Ireland. While this guide is primarily targeted at healthcare professionals, this information will also be of relevance to others including patients, manufacturers, distributors, and those working in hospitals with responsibility for sourcing biosimilar medicines.

Further information

You can find more information about the regulation of biosimilar medicines on the European Medicines Agency website. This includes a list of biosimilar medicines approved by the European Commission. Click on the name of each biosimilar medicine on the EMA website to learn more.

The European Commission has also published a Q&A for patients.

Video - Biosimilars explained.

If you would like more information, please see below video explaining biosimilars video explaining biosimilars.