Biosimilars

What is a biosimilar?

A biosimilar is a biologic medication that is almost an exact copy of another medication (the original product). According to the Food & Drug Administration (FDA), a biosimilar has no “clinically meaningful differences” from a product that has already been approved for use by the FDA. This means that both the original medication and the biosimilar lead to the same results when given to a person.

How is it different from the original medication?

Key traits such as safety, purity, and effectiveness of the biosimilar are compared to that of the original (also called reference) product. The biosimilar does not have to be exactly the same but must be highly similar. The medication will be evaluated and tested prior to FDA approval for use. The steps to be approved by the FDA are shorter for biosimilar products.

Is it the same as a generic medication?

A biosimilar is not the same as a generic medication. The active ingredients in a generic medication are exactly the same as the original medication. A biosimilar may have different inactive ingredients from the original medication. These ingredients will not change how the medication works. Both biosimilar and generic medications may offer a lower cost to the patient.

Are biosimilars as safe as the original product?

Biosimilars are made in FDA-licensed facilities and continue to be tracked by the FDA for safety. Because of these safeguards, prescribers and patients should not be concerned regarding the use of a biosimilar instead of the original medication.

Resources for More Information

The US Food & Drug Administration Biosimilars