The Drinker Biddle Life Sciences Team held a webinar panel discussion on the development of Biosimilars in the United States and abroad. The panel, moderated by John Jay Marshall, included Christine Norris, Debora Plehn-Dujowich and Doyle Siever. The group discussed an overview of regulatory issues, perspectives from the IP community, and practical advice in this rapidly developing area of the pharmaceutical industry, including:

  • FDA regulations and recently published draft guidance documents
  • Biosimilars activity abroad and how it may inform the US regulatory pathway
  • Strategies for pursuing the Biosimilars pathway
  • Preparing for Biosimilars litigation
  • Overcoming hurdles in Biosimilars development