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Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity

This article was originally published in The Pink Sheet Daily

Executive Summary

Hatch/Enzi/Hagan amendment retains the number from last year's bill, but a fight on floor seems possible.

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Biologics Exclusivity: Key Questions Unlikely To Have Clear Answers From US FDA

FDA’s embrace of biosimilars as part of the drug pricing response means a flurry of guidances coming soon. But don’t expect much clarity on key issues for innovators, like the boundaries of 12-year exclusivity and whether it will apply to NDA products that transition to BLAs, says a former CDER attorney.

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