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

Article

Biosimilar Webcast 1

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

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 Jacky Smith, MB, ChB, FRCP, PhD, professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust
 Jacky Smith, MB, ChB, FRCP, PhD, professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust
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