Call for rapid adoption of EU biosimilars guideline

The European Generic medicines Association (EGA) says it congratulates the European Medicines Agency and its Biosimilar Medicines Working Party for organizing a multi-stakeholder workshop, which took place yesterday (October 31), to discuss biosimilar guidelines which are at different stages of revision.

The Agency organized this workshop as part of its public-consultation exercise on its three draft revised overarching guidelines on biosimilars. The revised guidelines will further strengthen the pioneering role of the European regulatory and scientific framework for biosimilar medicines, according to the trade group.

Karl Heinz Emmert, head Biosimilar Project Leader at Israeli generic giant Teva, on behalf of the European Biosimilars Group (EBG), Sector Group of the EGA, commended the revision of the guideline on biosimilar medicinal products. It contains strong scientific principles to support the use of representative reference products sourced from highly regulated markets outside the European Economic Area.