Biosimilars: Exclusivity Guidance Possible; Head-To-Head Comparison Studies Sinking In
FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.
Learn what's happening at the US FDA. On the go.
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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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