EMA & FDA set up biosimilar 'cluster'

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on biosimilar medicines.

Clusters are topic areas of mutual interest for the two agencies, which they have identified as benefiting from the regular exchange of information and collaborative meetings. Biosimilar medicines is the latest addition to the existing list of topics, which already includes medicines to treat cancer, orphan medicines, medicines for children and blood-based products.

The new cluster will allow the two agencies to increase their degree of interaction and will begin with a kick-off meeting to discuss the group’s activities. The group will follow this with discussions by teleconference around three times a year.In the latest step in the two agencies’ ongoing collaboration on regulatory issues under their confidentiality arrangements, which they first signed in 2003.