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A biosimilar is a biological medicine that is highly similar to an already approved biologic called the reference product. It has no clinically meaningful differences from that product in safety, purity, or potency. Biosimilars are made from living sources and can contain minor expected variations, as all biologics do. An approved biosimilar provides the same expected treatment benefits and risks as its reference product.
read more about biosimilar ...Biosimilars are used in place of reference biologics for approved medical conditions. Available products can treat cancers, arthritis, inflammatory bowel disease, psoriasis, diabetes, eye diseases, kidney conditions, and other illnesses. A biosimilar can be prescribed to a person starting treatment or to someone who has already received the reference product. Its approved uses are based on scientific evidence showing biosimilarity and can include justified indications of the reference product.
A biosimilar has the same route of administration, dosage form, and strength as its reference product. It must work through the same mechanism for the approved condition when the mechanism is known. Expected treatment benefits, major risks, and potential side effects are the same. Minor differences in inactive components or natural biological variation are acceptable only when they do not affect clinical performance.
Regulators compare a proposed biosimilar directly with its reference product using analytical, functional, manufacturing, and clinical evidence. The goal is to show high similarity rather than repeat every study originally conducted for the reference biologic. Regulators assess structure, biological activity, purity, immune responses, pharmacology, safety, and other relevant data. Approval is granted only when the total evidence shows no clinically meaningful differences.
An interchangeable biosimilar is a biosimilar that meets additional legal requirements for pharmacy-level substitution in the United States. Depending on state law, a pharmacist can substitute it for the reference product without first contacting the prescriber. A biosimilar does not need an interchangeability designation for a clinician to prescribe it instead of the reference product. Both interchangeable and non-interchangeable biosimilars meet the same standard for biosimilarity, safety, and effectiveness.
No. Generic drugs usually copy small, chemically synthesized molecules, while biosimilars are highly similar versions of larger and more complex biologics. The approval standards account for these manufacturing and structural differences.
Yes. An approved biosimilar must have no clinically meaningful differences in safety and effectiveness from its reference product. Patients can expect the same treatment benefits and risks.
No. Interchangeability is a separate regulatory designation that a manufacturer must request. Clinicians can still prescribe an approved biosimilar without that designation.
Yes. Biosimilars can be used in patients who previously received the reference product. Treatment decisions and pharmacy substitution rules depend on the product, prescriber, insurance coverage, and applicable law.
Review and Approval. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/review-and-approval. Date Accessed August 5, 2026.
Biosimilars Basics for Patients. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients. Date Accessed August 5, 2026.
9 Things to Know About Biosimilars and Interchangeable Biosimilars. U.S. Food and Drug Administration. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars. Date Accessed August 5, 2026.
Biosimilar and Interchangeable Biologics: More Treatment Choices. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. Date Accessed August 5, 2026.
Biosimilar Product Regulatory Review and Approval. U.S. Food and Drug Administration. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Date Accessed August 5, 2026.