The RED TAPE ELIMINATION ACT (S2305) or the Lee bill is intended to increase biosimilar competition and reduce patient costs by prohibiting the US Food and Drug Administration (FDA) from requiring switching studies to approve a biosimilar as interchangeable. It is hoped that eliminating this barrier will increase access to lower-cost biosimilars and save payers and consumers billions over the next five years, as well as to enhance patient and physician confidence in biosimilars.

Acquiring interchangeable status requires the product to undergo switching studies whereby participants must alternate between the biological and the biosimilar.  Senator Lee’s office is of the opinion that switching studies are unnecessary for biosimilars to obtain interchangeable status.

However, an interchangeable biosimilar is a unique biosimilar standard to the US, and the interchangeable biosimilar designation has successfully built physician and patient confidence. Weakening the standard for interchangeable biosimilars by applying it to all biosimilars – including those which have not provided additional data – would have immediate and harmful effects nationwide.

This webinar aims to educate policymakers, healthcare providers, and patients on the current regulatory framework for biosimilars in the US in order to understand the need to maintain the FDA’s current robust interchangeable biosimilar approval standard and the impact on patient safety and treatment efficacy that could arise from lowering that standard. 

SPEAKERS/PANELISTS:
Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines
Ralph McKibbin, MD, FACP, FACG, AGAF, Past President of the Pennsylvania Society of Gastroenterology and the Digestive Disease National Coalition, USA
Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Ohio State University, USA
Andrew Spiegel, Esq, Executive Director, Global Colon Cancer Association

Download the full programme!

Online event hosted by the Alliance for Safe Biologic Medicines in collaboration with GENERICS AND BIOSIMILARS INITIATIVE.