Medicines play a vital role in improving the overall health of Irish patients. Securing access to new and innovative medicines, in a timely manner, is a key objective of the Irish health service. However, the challenge is to deliver this objective in an affordable and sustainable way. This requires an integrated approach to reduce the price of all treatments, to deliver greater efficiencies across the supply chain and also to promote the use of the most cost-effective treatments.

To address some of these challenges, the Government is developing a National Biosimilar Medicines Policy to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.

A biosimilar is a biological medicine that is highly similar to an approved biological medicine (the reference medicine). Biosimilar medicines can only be authorised for use once the patent for the reference medicine has expired. However, they have no clinically meaningful differences compared to the reference medicine. Biosimilars are typically less expensive to produce than the reference medicine, due to lower research and development costs. As a result of the lower costs and competition for market share, they are generally priced at a significant discount to the reference medicine.

The National Biosimilar Medicines Policy is being drafted in anticipation of the expiration of a number of biological patents over the next few years. The policy will aim to increase biosimilar use in Ireland, by creating a robust framework in which biologicals and biosimilars can be safely, cost-effectively and confidently used in the health service.