The EU Biosimilars Flagship Event
Come and meet the leading EU and International Regulators and Experienced EU Companies

  • Current status and future outlook of the biosimilar medicines market
  • Biosimilars business opportunities beyond the EU and the USA
  • Next steps of the “Tajani initiative” and the European Commission industrial policy strategy
  • Update on biosimilars utilisation and best practices around Europe supporting uptake
  • Outcome of the GfK Bridgehead report on the sustainability of the biosimilars market
  • Most recent developments regarding EMA pioneering guidelines
  • Progress on global framework for biosimilar development: insight from EMA, FDA and KFDA
  • EU extensive experience with biologics prescribing, naming, traceability and pharmacovigilance
  • Extrapolation of indications: regulators’ experience with assessment of the first biosimilar monoclonal antibody
  • Biosimilarity concept: a paradigm shift for many key stakeholders
  • Biosimilars for doctors: interactive panel session with renowned clinicians and key EU regulators
  • Pre-conference BIOSIMILARS MASTER CLASS "Global development of biosimilars – vision or reality? Where is the US?" - Thursday 3 April 2014 from 09:00 till 13:00

    (Open to conference delegates who have registered separately for the Master Class)

  • Will global biosimilar development work? Can we create viable candidates while the US plays catch up? Or will European biosimilars become standalone biologics in the US?
  • How can uncertainties in US market access be mitigated, and will their regulatory & commercial environments develop in parallel?
  • The US represents 50% of the global biologics market by value, but is it one market or many? Does progress in US Health Care Reform alter this? Will the US biosimilar market resemble the EU and if so how?
  • How has the EU market changed since the first biosimilar was launched in 2006?

    “Join us for an interactive Biosimilars Master Class led by Gillian Woollett, MA, DPhil and Mateja Urlep, respectively Senior Vice President, Avalere Health and Founder & CEO, TikhePharma, where you can address all your questions in a shared and informal setting”
  • Media Partners & Event Sponsors
    Biosimilars News
    Generics Bulletin
    Pharma Connections Worldwide
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