Brand-backed association the Alliance for Safe Biologic Medicines has expressed caution over FDA findings that bolster the case for biosimilar switching and suggest a reduction in the need for switching studies to support interchangeability.
Caution has been raised in a paper published by the Alliance for Safe Biologic Medicines over recent developments affecting biosimilars in the US, particularly in regard to the regulatory approach to biosimilar switching and interchangeability.
The ASBM styles itself as “an organization composed of diverse healthcare groups and individuals” who are “working together to ensure...
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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.’
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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