WORKSHOP A: BIOSIMILARS EUROPE

Dec 2, 2019 9:00am – 12:00pm

Working Group on The Regulatory and Economic Framework for Biosimilar Drugs in Europe

Europe has been the global leader for Biosimilar medicines since 2006 with the approval of the somatotropin biosimilar. Since then and to date, 53 biosimilars of 18 different active substances have been approved under the EMA’s biosimilar guidelines

This three-hour interactive workshop session will provide you with a comprehensive picture of the current European Biosimilar landscape from regulatory approval to economic considerations to litigation assessment. Thus, giving you all the right tools and knowledge equipped for success in your biosimilar launch in the European market

PART 1: REGULATORY PATH APPROVALS

  • Assessing how biosimilars are defined and authorised in Europe
  • Analysing the current regulatory legal framework applicable to biosimilars
  • Developing best practices for product approval at the EMA
  • Reviewing pricing and reimbursement considerations for biosimilars
  • Exploring the interchangeability of biosimilars and national substitution policies

PART 2: ECONOMIC CONSIDERATIONS

  • Analysing the current uptake of biosimilars drugs in the EU
  • Understanding the elevated costs associated with developing and manufacturing biosimilar products and related regulatory barrier impacting the price of biosimilar drug
  • Evaluating the current biosimilar drug reimbursement structure in the EU

PART 3: LITIGATION ASSESSMENT

  • Deep dive case examination for biosimilar litigation:
    • Fujifilm Kyowa Kirin Biologics and Samsung Bioespsis UK vs AbbVie
    • Genentech vs Pfizer