Biosimilar “Interchangeability” Standard Is Double-Edged Sword For Generics
The interchangeability standard for follow-on biologics set out in Senate legislation creates a relatively smooth pathway for generic firms to seek approval of such products, but could also lead to an extended struggle to win acceptance for such products in the marketplace
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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