EU Updates Definition Of ‘Similarity’ For Orphans In View Of Advances In Gene And Cell Therapies
Executive SummaryPractical advice has also been issued on how the concept of similarity should be applied to advanced therapy medicinal products.
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Industry seeks clarity as to when a subsequent product will be judged the ‘same’ as a previously approved product that holds seven years of blocking exclusivity. CBER Director Marks says agency is working to put its views in writing soon but notes the US and EU may be headed in different directions on the issue.
The European Commission has proposed changes to the existing criteria used for determining whether a new medicinal product is similar to an already authorized orphan drug and, therefore, whether it can be accepted for evaluation and granted 10-year market exclusivity.
The European Medicines Agency is working on a definition for 'principal molecular structural features'- a term in the EU orphan drugs legislation for determining the similarity between a drug in the pre-authorization phase and a drug that has already received orphan designation or market authorization.