Biosimilars: Why 2016 Is a Game-Changer - Webinar CD/Transcript
Biosimilars: Why 2016 Is a Game-Changer
The FDA has been criticized for its lack of guidance regarding biosimilars.
There are biosimilars in the pipeline waiting for approval — but how long will they sit in the queue?
Just one product, Zarxio, a biosimilar of the Amgen product Neupogen, has been approved to date. But things are changing.
In 2016, it is expected that the FDA will intensify its development of a biosimilars regulatory framework and review multiple proposed biosimilar products. This FDA activity will still provide just glimpses of the emerging biosimilars landscape.
Nathan Doty, Associate Director of Biotherapeutics Regulatory Affairs at AbbVie, covers the following issues affecting biosimilars:
- Potential regulatory actions by FDA on biosimilars issues
- Analysis of recent FDA regulatory actions surrounding biosimilarity
- Analysis of the biosimilar market landscape
- Identification and analysis of scientific, regulatory, and policy issues related to the approval of biosimilars and their role in the market post-approval.
A deep understanding of current and potential biosimilar regulatory activities as well as thoughtful projections about the market for these products will be essential in any attempt to be prepared for a world where biosimilars are approved, marketed and prescribed.