A biosimilar medicinal product is a biological medicine which is similar to another biological medicine that has already been authorised for use, often called the “reference medicinal product”.

The increased biosimilar competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class, as is highlighted in this recent report on the impact of biosimilar competition conducted by IMS Health on the request of the European Commission.

The document, which is an update of the report published first in May 2015, describes the effects on price, volume and market share following the market entry of biosimilars in the European Economic Area.

One of the key arguments for introduction of biosimilars is to increase patient access by driving down prices. The four established therapy areas with biosimilar competition show indeed a consistent picture of reduced average prices. Above all in countries with initial low usage the price reductions seem to have a significant impact on the increased access of patients to biological medicines.

The document is based on a set of indicators which were deemed to be appropriate for monitoring the market development and the impact of biosimilar competition. This 2016 report was prepared on the request of the European Commission and in co-operation with industry stakeholders. The report contains a set of observations and a reading guide.

The report was presented on 20 June 2016 in Brussels at the stakeholder conference on biosimilars organised by the European Commission. The outcomes of the stakeholder event will be made available on the Commission’s website.

More information

Biosimilars in the EU (see Platform on Access to Medicines in Europe -> Projects)