Biosimilars Pathway Dilemma: When Should Sponsors Pick (k) Before (a)?
Extrapolation and interchangeability appear to be the linchpins for biosimilar sponsors mulling whether to send applications to the emerging 351(k) pathway or the traditional novel biologics approval system.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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