Biosimilars in IBD: Slides from the 2017 ACG Workshop with the FDA and EMA

On October 23, The U.S. Food and Drug Administration (FDA) released a public bulletin on biosimilar drugs.  The FDA has recently has approved biosimilar products to treat conditions such as cancer, Crohn’s disease and colitis, irritable bowel syndrome, and more.  But what are biosimilars?  The FDA continues to roll-out educational materials for providers.

What are the practical implications for GI clinicians prescribing IBD medications?

ACG’s FDA Related Matters Committee hosted a public workshop with the FDA and the European Medicines Agency (EMA) and addressed this question at the WCOG at ACG 2017.  The workshop compared the approval processes of biosimilar drugs in both agencies, with a focus on IBD.  The EMA provided some insight from their history of approving biosimilar drugs in IBD.  The FDA also provided some practical tips for ACG members and GI clinicians.  Did you miss this workshop?  In need of some practical guidance?

Check out the slides here:


Stephen Hanauer, MD
Professor of Medicine
Northwestern University Feinberg School of Medicine
ACG Past President


Sue Lim, MD
Medical Officer Team Leader
Division of Therapeutic Biologics and Biosimilars

Dr. Lim provided an overview of the FDA biosimilar approval process, with a focus on IBD.
Click to view her slides.

Joachim Musaus, MD
Scientific Administrator
Rheumatology, Respiratory, Gastroenterology & Immunology
Scientific and Regulatory Management Department
European Medicines Agency

Dr. Musaus provided an overview of the EMA biosimilar approval process, providing some history on EMA’s approval of biosimilars for IBD.
Click to view his slides.

Tara Altepeter, MD
Clinical Team Leader
Division of Gastroenterology and Inborn Errors Products

Dr. Altepeter provided a practical overview of biosimilars in IBD and tips for ACG members.
Click to view her slides.