What are Biosimilars?

Biosimilars are safe and effective medications approved by the U.S. Food & Drug Administration (FDA). They are called biosimilar because they are a type of medication known as "biologics" (medications created from living organisms and designed to target a certain site in the body) and are made in a way that mirrors the process of a biologic medication that has already been approved by the FDA (often referred to as the reference product). Biosimilars work the same way in your body as the reference product. Any differences between the biosimilar and the reference product are carefully reviewed by the FDA before the biosimilar is approved to ensure the biosimilar is as safe and effective as the reference product.

Biosimilars are not generics of the reference product. Generic drugs are considered “simple molecules” and are an exact copy of the brand name drug. Biosimilars are complex molecules that require a specialized manufacturing process to create a similar product. Like generics, biosimilars are often less expensive than the original product. The lower cost is not a reflection of the effectiveness or safety of the biosimilar but a result of increased supply and faster development with the use of available information from the reference product. Many biosimilar manufacturers offer a copay savings program to help with any out-of-pocket expense.

Biosimilars are:
•As effective as the reference product

•As safe as the reference product, having the same potential side effects

•Sometimes less expensive (depending on manufacturer assistance) than the reference product

•Carefully reviewed by the FDA before and after approval

To learn more about Biosimilars, you can visit https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients

Reviewed 3.2024