A biosimilar is a type of biologic medication. Biologics are medicines made from living organisms that have had a major impact on the treatment of many medical conditions, including IBD. Biosimilars are developed to be highly similar, but not identical to a biologic in the market that is already FDA-approved. The original biologic against which the biosimilar is evaluated is often referred to as the “reference product.” 

To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health-care professionals and patients about biosimilars and how they can be used for IBD patient care. 

FDA approval process
The process to make a biosimilar is very complex, and the U.S. Congress has created a unique process for biosimilars’ approval. For a biosimilar to be approved by the FDA, it must meet strict requirements to show that it works the same way as the reference product, and produces no meaningful clinical differences in terms of safety and effectiveness from the reference product. It must also have the same mechanism of action, route of administration, dosage form and strength as the reference product.

Many biologics have come off patent or will soon come off patent. This has provided drug manufacturers with the incentive and opportunity to develop biosimilars to compete with existing biologics. As the market for biologics and biosimilars grows, having new products available will benefit health-care providers and patients by increasing treatment options and improving access to important medicines at lower costs.

Educate your patients


Patient Guide

Interactive, online patient education developed with outside partners.

What Are Biologic and Biosimilar Drugs? A Guide For Patients Living with Inflammatory Bowel Disease

Order free copies of this guide here


Educate Yourself