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Biosimilars Conference

Session 2: The Pitfalls and Promises of Real World Evidence in Evolving the Biosimilar Industry

Session Chair(s)

Mark  Stewart, PhD

Mark Stewart, PhD

  • Vice President, Science Policy
  • Friends of Cancer Research, United States
Anna  Welch, MA

Anna Welch, MA

  • Chief Editor, Biosimilar Development
  • Life Science Connect, United States

Real world evidence has been a critical tool for reassuring stakeholders of the long-term safety and efficacy of biosimilars. But how else can RWE shape the evolving use of biologics and biosimilars? This panel will discuss the challenges of collecting and using RWE today to improve biosimilar understanding. It will also identify other areas of inquiry that can be addressed with RWE and the existing potential of RWE to evolve regulatory requirements and clinical treatment pathways.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Evaluate current best-practices and challenges in RWE collection, analysis, and promotion
  • Assess evolving strategies for employing RWE in education
  • Discuss the impact RWE can have on pre-approval clinical data and the treatment pathway


Jaclyn  Bosco, PhD, MPH


Jaclyn Bosco, PhD, MPH

  • Senior Director, Global Scientific Head, Epidemiology and Outcomes Research
  • IQVIA, Real World Solutions, United States
Nancy  Lin, DrSc, MS


Nancy Lin, DrSc, MS

  • Senior Scientist, Epidemiology
  • Optum, United States
Edward  Li, PharmD, MPH


Edward Li, PharmD, MPH

  • Associate Director, HEOR & RWE
  • Sandoz, United States
Gianluca  Trifiro, MD, PhD


Gianluca Trifiro, MD, PhD

  • Associate Professor of Pharmacology, Dept of Biomedical and Dental Sciences
  • University of Messina, Italy

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