Biosimilars: Why 2016 Is a Game-Changer - Webinar CD/Transcript

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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.

Anyone interested in the development of the biosimilars market and the progress toward developing the framework for the regulation of biosimilars including:

  • Pharma and payer general counsel/associate general counsel
  • Pharma regulatory affairs staff
  • Pharma and payer VPs and C-level executives

Nathan Doty is Associate Director of Biotherapeutics Regulatory Affairs in the Biologics Strategic Development team at AbbVie. Nathan works on biosimilars regulatory issues at the company. Nathan joined AbbVie in Fall 2015 after spending six years working at the Food and Drug Administration — three years in the Office of the Chief Counsel and three years in the Office of the Chief Scientist, within the Office of the Commissioner.