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Biosimilars Conference

Session 4: A Success of Our Own: How Do We Define the U.S.’ Biosimilar Success Story?

Session Chair(s)

Leah  Christl, PhD

Leah Christl, PhD

  • Executive Director, Global Biosimilars Regulatory Affairs and Regulatory & R&D P
  • Amgen, United States
Tiffany  Fletcher, MA

Tiffany Fletcher, MA

  • Head of Global Biosimilar Policy and Access
  • Viatris, United States
The Biologics Price Competition and Innovation Act was signed into law on March 23, 2010 creating an abbreviated approval pathway for biosimilar medicines. The first biosimilar was approved in the US in 2015. As of today, FDA has approved 26 biosimilars and 17 have launched into the US market. As we analyze how the market has developed over the last 10 years, it is important to understand the progression of the market and answer an important question: What does success look like for the biosimilars in the U.S.? We will discuss the following:
  • What are the metrics of success?
  • Does the measure of success differ between product types, sites of care, disease states, & stakeholder groups?
  • What is the vision of success that is or is not being met today?
  • What is the U.S.’ definition of biosimilar market “equilibrium”? (i.e., the balance between success and failure)
  • In what ways are biosimilars addressing health disparities and access to care, and should this factor into the evaluation of success?
  • How are biosimilars laying the groundwork for the appropriate amount of reinvestment in innovation?
Learning Objective :
  • Evaluate the current development of the biosimilar market in the U.S.
  • Define the appropriate metrics to measure the success/failure of the US biosimilars market
  • Analyze the impact of biosimilar competition in the US on market access and healthcare economics
  • Compare/contrast the differing levels of success for the different products and sites of care
  • Create a framework for assessing the future success of biosimilars in the U.S.


Ronny  Gal, PhD


Ronny Gal, PhD

  • Senior Research Analyst
  • AllianceBernstein LP, United States
Chad  Pettit, MBA


Chad Pettit, MBA

  • Executive Director, Marketing, Global Biosimilars Commercial Lead
  • Amgen Inc., United States
Chrys  Kokino, MBA


Chrys Kokino, MBA

  • Head of Global Biologics Commercial
  • Mylan, United States
Kevin Brian Knopf, MD, MPH


Kevin Brian Knopf, MD, MPH

  • Division Chief Hematology/Oncology
  • Highland Hospital, United States
Mohannad  Kusti, MD, MPH


Mohannad Kusti, MD, MPH

  • Regional Medical Director
  • Pivot Onsite Innovations, United States