Biosimilars: Overview of the European Medicines Agency (EMA) Experience

Biosimilars: Overview of the European Medicines Agency (EMA) Experience [Enduring Webcast]

This webcast is brought to you by Amgen.

The faculty for this webcast:

  • Described the regulatory pathway for European Medicines Agency (EMA) approval of biosimilars
  • Discussed key requirements for biosimilar product approval based on EMA scientific guidelines
  • Compared an innovator application versus a biosimilar application data package
  • Described the challenges with pharmacovigilence
  • Discussed product naming and automatic substitution
  • Reviewed approvals, withdrawals, and rejections of biosimilar application submissions to EMA
  • Highlighted regulatory pathways established by other countries for biosimilars

Length of webcast: 14 minutes

System Requirements

PC-based attendees

Required: Windows® 7, Vista, XP, 2003 Server or 2000

Macintosh®-based attendees

Required: Mac OS® X 10.4.11 (Tiger®) or newer

70576-R1-V1