Biosimilars

A biosimilar is a complex medicine that is highly similar to the brand name biologic it references, and does not have any clinically meaningful differences in safety, purity, or potency.

Biologic medicines are complex medicines made from living cells.

Biosimilars are used to treat a variety of diseases, like rheumatoid arthritis, Crohn’s disease, and cancer. They are the generic competitors to more expensive brand biologic medicines.

All biologic products, including biosimilars, must meet the rigorous safety and efficacy standards set by the U.S. Food and Drug Administration (FDA).

An interchangeable designation is unique to the United States, and is not an indication of superior quality. This designation allows a pharmacist, subject to state law, to substitute and dispense a biosimilar when a patient’s doctor prescribed the reference biologic.

A reference product is the single biologic product, already approved by FDA, against which a proposed biosimilar product is compared.

No, generic medicine and the original brand small molecule product are produced by chemical processes. A biosimilar medicine is a highly similar version of an original brand of a biological medicine.

In the United States, all biosimilars must meet the safety and efficacy standards set by the FDA before they are made available to patients. Biosimilars must prove that they can treat a patient with no clinically meaningful differences from the reference product in terms of safety, purity and potency.

Your doctor and healthcare team are always your best source of information. For information about specific biologic or biosimilar medicines, you can browse the FDA’s website here. Our Helpful Links page lists additional resources we hope you find useful.