Agenda – Biosimilar Market Access and Commercialization Strategies Summit

  • Day One
  • Day Two

Day One

 Monday, September 18

9:00AM – 12:00PM

Uncover Market Access of Biosimilar in the U.S. Market

While the biosimilar market continues to develop, much remains unanswered to ensure the commercial success of biosimilars in the United States. It is essential for manufacturers and product innovators to understand the approval pathways and familiarize themselves with the major issues surrounding market access and evaluation of biosimilars.

This workshop will help stakeholders identify key issues related to the U.S. biosimilar landscape and review effective strategies for market access.
Commercialization of Biosimilars: Navigating the Crossroads Between Business Development, Product Development, and Strategic Portfolio Management

  • Analyze the issues, challenges and impacts of market access unknowns for biosimilars in the U.S. market
  • Learn best practices for when to start/update market analysis for a new biosimilar program
  • Implement data–driven rationale for biosimilar pipeline
  • Discuss common pitfalls and realistic timelines in designing a biosimilar program

Pricing and Naming Considerations for Biosimilar Pipelines

  • Review the topics to consider when developing biosimilar pricing strategies
  • Examine the current dialog over biosimilar naming
Kristi Sarno, Senior Consultant, Latham BioPharm Group; Former Director Business Development, PFENEX, INC.

There will be a half–hour networking break at 10:00.


1:00PM – 1:45PM

Chairperson’s Opening Remarks:
Build Effective Biosimilar Strategies From Commercialization

John Coelho, Global Medical Strategy Leader, MERCK

1:45PM – 2:30PM

Uncover Emerging Trends and the Future of Biosimilar Drug Market in the United States

Chrys Kokino, Head Global Biologics Commercial, MYLAN

2:30PM – 3:15PM

Analyze the Biosimilars Pipeline and the U.S. Market Evolution
Ashish Dugar, former Officer and Vice President, Commercial Development, INTRA-CELLULAR THERAPIES

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Economics Impacts of Biosimilars
Joseph P. Fuhr, Ph.D., Adjunct Faculty College of Population Health and Professor Emeritus of Economics, WIDENER UNIVERSITY

Day Two

 Tuesday, September 19

9:00AM – 9:15AM

Chairperson’s Recap of Day One
John Coelho, Global Medical Strategy Leader, MERCK

9:15AM – 10:00AM

The Interchangeability Guidance and the Opportunity and Efficient Approval of Interchangeable Biologics
Bruce Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS

10:00AM – 10:45AM

Kaiser Permanente’s Biosimilar Experience

Ambrose Carrejo, Pharmaceutical Contracting Leader, KAISER PERMANENTE

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Discuss Reimbursement Considerations for Biosimilars
Molly Burich, Associate Director Public Policy, BOEHRINGER INGELHEIM

12:00PM – 1:00PM


1:45PM – 2:30PM

Benchmark Complex Factors to Decide Between Biobetter Versus Biosimilar Development Options
Rakesh Dixit, Ph.D., DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, MEDIMMUNE, ASTRAZENECA GROUP

2:30PM – 3:15PM

A Biosimilar Delayed Is a Biosimilar Denied
Sarfaraz Niazi, Ph.D., Adjunct Professor, Department of Biopharmaceutical Sciences, UNIVERSITY OF ILLINOIS AT CHICAGO, COLLEGE OF PHARMACY

3:15PM – 4:00PM

Obstacles to the Adoption of Biosimilars for Chronic Diseases
Aaron Hakim, Researcher, Yale University School of Medicine