Can one proceed with Pre-clinical/Clinical trials for a biologic/biosimilar IF the competitor has been FDA approved (NDA or BLA) and is granted 7 year market exclusivity? Would the FDA block the biologic/biosimilar for a certain period prior to pre-clinical/clinical trials?
Hinal Desai
according to me,Market exclusivity, only precludes a second sponsor (that is you in your case)from obtaining approval to provide an identical drug for the identical orphan indication for which the first sponsor received exclusive market approval.you can get the approval of different orphan drug for same orphan i.e rare disease which the first sponsor is treating...
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