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Monday, June 25 • 3:00pm - 4:00pm
#152: FDA Expectations for Demonstration of Interchangeability

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

Biological products which are biosimilars of reference products are not automatically interchangeable under FDA guidelines. This session will detail our current understanding of FDA expectations for demonstration of interchangeability of a biological product with a reference product with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.

Learning Objectives

Compare and contrast biosimilarity versus interchangeability; Describe an overview of FDA expectations for demonstration of interchangeability; Describe standalone versus combined interchangeability study designs.


Kamali Chance


FDA Overview of Considerations in Demonstrating Interchangeability With a Reference Product
Leah Christl, PhD

Industry Perspective of the FDA Interchangeability Guidance
Hillel Cohen, PhD

avatar for Kamali Chance

Kamali Chance

Chief Regulatory Officer, Biosciences Corporation
Dr. Chance has extensive regulatory strategy/ regulatory affairs experience working for a Clinical Research Organization and pharmaceutical and biopharmaceutical companies. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory... Read More →
avatar for Leah Christl

Leah Christl

Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States
Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →

Monday June 25, 2018 3:00pm - 4:00pm EDT
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session