Pediatric Exclusivity For ‘Deemed’ Biologics Needs Clarity, Industry Tells US FDA
Executive Summary
Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.
You may also be interested in...
'Authorized Biosimilars' Cannot Use 351(k) Pathway
FDA's position will impact what types of biosimilar and interchangeability applications can be submitted for insulin and other "deemed" protein products. Agency says in final draft Q&A guidance on transition provisions that the holder of a standalone BLA cannot reference its own product in an application for a bisoimilar or interchangeable version.
'Authorized Biosimilars' Can't Use 351(k) Pathway, US FDA Concludes
FDA's position will impact what types of biosimilar and interchangeability applications can be submitted for insulin and other "deemed" protein products. Agency says in final Q&A guidance on transition provisions that the holder of a standalone BLA cannot reference its own product in an application for a bisoimilar or interchangeable version.
When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'
With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.