On the 30th May, the European Commission published Regulation 2018/781, which has amended Regulation (EC) No 847/2000 regarding the definition of the concept “similar medicinal product”.
Regulation No 847/2000 had provided a definition of “similar medicinal products” and a number of cases defining what kind of products are to be regarded as similar for the purposes of the application of the OMP (Orphan Medicinal Products) incentives. However, the Commission felt that innovations in biological medicines, such as in advanced therapy medicinal products (ATMPs) and cell therapies, had caused this definition to become outdated. Similar medicinal products are those which contain a “similar active substance” or substances. The regulation expands the definition of “similar active substance”, by providing that:
“in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics.”
It also gives detailed guidance on what is meant by “molecular structural features” in the context of chemical, biological and radiopharmaceutical medicinal products.
Regulation 2018/781 will enter into force on 19th June 2018.