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.

The safety, purity, and effectiveness of the biosimilar is compared to the original (also called reference) product. The biosimilar does not have to be exactly the same but must be very similar. The medication is tested before FDA approval for use.

The biosimilar and the original biologic both have the same treatment benefits, are given the same way, are made from the same type of natural sources, have the same potential side effects, and have the same strength and dosage.

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