European Medical Journal (Sep 2018)
Switching from Reference to Biosimilar Products: An Overview of the European Approach and Real-World Experience So Far
Abstract
Switching patients from a reference to a biosimilar product has become a primary topic of interest, with different approaches being undertaken by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In European countries, substitution of a reference medicine with a biosimilar product is encouraged for treatment-naïve patients. However, a more cautious approach has been taken with regard to switching patients on the reference product to a biosimilar product, with differences across countries. In general, there is a tendency to encourage the switch to biosimilars if conducted under the supervision of a clinician, with a few exceptions for substitution at the pharmacy level being permitted. There is also a general agreement that no further clinical trials are needed to allow any kind of switching, including automatic substitution, which differs from what is required by the FDA. With massive numbers of non-medical switches taking place in some European countries, as well as an increasing number of post-marketing studies being conducted, a growing amount of data on switching from originator to biosimilar products are becoming available. The data recorded so far suggest that switching is not detrimental for patients both in terms of safety and efficacy, although there have been some reports of increased treatment discontinuation rates after switching. Therefore, large-scale and long-term data are warranted to provide a more robust assessment of the effects of single or multiple switching. In addition, in Europe, the use of biologics has increased since their emergence, in particular in countries with historically poor access to biological medicines, and the tendency to promote the use of cheaper biological drugs is expected to increase further in the future. A communication strategy involving the patient and all other stakeholders that focusses on the patient’s specific circumstances and information needs will play a crucial role in the conduction of a successful switch. An overview of switching policies across Europe together with outcomes from clinical trials and real-world evidence data is presented in this review.
