Changes To EU Orphan Similarity Concept Could Change Innovation Threshold For 10-Year Exclusivity
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.
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Practical advice has also been issued on how the concept of similarity should be applied to advanced therapy medicinal products.
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.
EU pharmaceutical companies have welcomed new European Commission guidance that provides greater clarity on how several key provisions of the legislation on orphan drugs should be applied in practice.