The biotechnology industry wants the US Food and Drug Administration to clarify how it will apply the concept of “sameness” for orphan product exclusivity purposes to cell and gene therapies.
The FDA’s response: We’re working on it.
Orphan Products: US FDA Working On ‘Sameness’ Policy For Cell And Gene Therapies
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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.
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