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Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says

Loeb & Loeb Food & Drug Administration partner Jim Czaban, was quoted in Pink Sheet discussing the FDA's recent memo describing the first interchangeable biosimilar exclusivity decision and the anticipated guidance based on these interpretations. 

“The memo can be seen as an exercise of FDA’s adjudicatory function and authority, and it’s natural that the agency would explain the bases of its decision. If and when the FDA does issue general formal guidance on [first interchangeable exclusivity (FIE)] issues, the substantive interpretations from this memo would likely be repeated in such guidance, presumably along with discussion of how FDA would address FIE issues under different fact patterns,” Jim says.

To read the full article, visit the Pink Sheet website (subscription may be required).