Pharma Welcomes Clarity On Similarity Assessment Of ATMPs Under EU Orphan Law
Executive Summary
As the European Commission reviews the concept of similarity within the context of EU orphan drugs legislation, it has introduced a new section on advanced therapy medicinal products to clarify how similarity assessments should be carried out for such products. While the industry has welcomed this new guidance, it urges caution on this front as R&D in this field is still evolving.