Biosimilar Medicines

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

A biosimilar is a biological medicine that is highly similar to another biological medicine (know 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

We have a leaflet available with 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. If you wish to receive a copy of our leaflet in PDF or print format, you can request one by emailing communications@hpra.ie. 

HPRA Guide to Biosimilar Medicines

This guidance document provides helpful information on the regulation, prescribing, dispensing and traceability of biosimilar medicines in Ireland. While primarily targeted at healthcare professionals, this information will also be of relevance to others including patients, manufacturers, distributors and those involved in hospital procurement.

In October 2017, the HPRA hosted an information evening for healthcare professionals to outline how biosimilar medicines are approved for use in patients. You can view the presentation slides from this event on our website.

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