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Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Executive Summary

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

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'Authorized Biosimilars' Can't Use 351(k) Pathway, US FDA Concludes

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