FDA Offers Clarity On Biosimilar Interchangeability
Guidance Provides Draft Q&As On Applications And Labeling
A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.
You may also be interested in...
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
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.
A much-anticipated biosimilars action plan (BAP) unveiled by US Food and Drug Administration (FDA) commissioner Scott Gottlieb has been warmly received by industry. Commending the release of the plan, the US Association for Accessible Medicines (AAM) called it “another key plank in the FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines”.