Orphan Medicinal Products - Publication of Regulation Updating Definition of "Similar Medicinal Products"

• 30/05/2018
• Articles

Today’s Official Journal of the European Union features a Commission Regulation (EU) 2018/781 of 29 May 2018 “amending Regulation (EC) No. 847/2000 as regards the definition of the concept ‘similar medicinal product’” (the “Regulation”).

Orphan medicinal products benefit from a 10-year period of orphan market exclusivity. During this period, no marketing authorisation applications can be accepted and no marketing authorisations can be granted or extended for the same therapeutic indication in respect of a “similar medicinal product”. Hence, the concept of “similar medicinal product” is key for determining the scope of orphan market exclusivity.

The Regulation updates the definition of a “similar medicinal product” in the light of new scientific and technical knowledge, in particular major developments in the field of biological medicines, including advanced therapy medicinal products. The update also considers the experience gained with regard to the designation and regulation of orphan medicinal products.

Furthermore, the Regulation defines the concept of “principal molecular structural features” which is an element of the definition of “similar active substance”, which in turn forms part of the definition of “similar medicinal product”. As the “principal molecular structural features” of advanced therapy medicinal products, such as cell-based and gene therapies, cannot be fully defined, the similarity between two active substances will for these products be assessed on the basis of the “biological and functional characteristics”.

The Regulation will enter into force on 19 June 2018.