Learning Tracks

The U.S. biosimilar market continues to grow, with new adoption and approvals happening faster than ever before. However, a lack of understanding regarding key issues surrounding interchangeability continues to slow biosimilar uptake, confuse providers and patients, and contribute to limited options for substitution at the pharmacy-level. Recent draft guidance from the FDA regarding the removal of switching studies intended to support a demonstration that a biological product is interchangeable with a reference product is a step in the right direction, but there is still more decisive action that can be taken to remove stigma around biosimilars without the ‘interchangeable’ designation. This panel will discuss the science and rationale behind why the default switch to nearly all biosimilars being considered interchangeable can have a profound effect on biosimilar uptake and patient acceptance, leading to a more sustainable biosimilar ecosystem that benefits patients and the health system.

Adam Colborn, JD
Associate Vice President, Congressional Affairs, AMCP

Michelle Cope
Director, Federal & State Pharmacy & Regulatory Affairs, National Association of Chain Drug Stores (NACDS)

Sam Leo
Senior Director, U.S. Biosimilar Operations, Teva Pharmaceuticals

Heather Pace, PharmD
Senior Clinical Manager, Vizient Inc.

Moderator: Alisha Sud
Director, Policy, AAM