'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.
You may also be interested in...
Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.
Semglee, a follow-on version to Sanofi’s Lantus, finally wins approval more than two months after insulin products transitioned to regulation as biologics; the product is not a biosimilar but can serve as a reference biological for future biosimilar or interchangeable applications from other sponsors.
Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.