FDA-approved biosimilars are safe and effective biologic medications that are highly similar to biologic medications already approved by FDA – called “reference products.” There are no clinically meaningful differences in safety, purity, or potency (safety and effectiveness) between biosimilars and their reference products.
An interchangeable biosimilar product is a biosimilar that, depending on state pharmacy laws, may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care professional (similar to how generic drugs are routinely substituted for brand-name drugs). Biosimilars and interchangeable biosimilars may help increase patient access to biologic medications.
Here are some things to know about biosimilars and interchangeable biosimilars:
FDA-approved biosimilars and interchangeable biosimilars are highly similar versions of FDA-approved reference products.
Biosimilars and interchangeable biosimilars are made from the same types of sources as the reference products, such as living cells or microorganisms. Biosimilars work the same way as the reference product and are also given the same way (such as a subcutaneous injection or an intravenous infusion). They also have the same strength and dosage as the reference product.Biosimilars and interchangeable biosimilars are as safe and effective as the reference product.
Both biosimilars and interchangeable biosimilars must meet the same high standard of biosimilarity for FDA approval. This means you can expect the same safety and effectiveness over your course of treatment as you would from the reference product. Research by FDA has shown that switching between biosimilars and their reference products is not associated with differences in the risk of death, serious adverse events, or treatment discontinuations.Some biosimilars are approved as "interchangeable biosimilars."
Some, but not all, biosimilars are approved as interchangeable biosimilars. A company has to specifically request approval of its biosimilar as interchangeable. There are reasons why a company may not seek a determination of interchangeability, such as business reasons, or because the medication is administered at a hospital or outpatient clinic and would not be dispensed to the patient by a pharmacy. Depending on state laws, a biosimilar typically has to be prescribed by name, while an interchangeable biosimilar may be substituted for the reference product at a pharmacy without the intervention of the prescriber.Health care professionals can prescribe both biosimilars and interchangeable biosimilars in place of the reference product with equal confidence.
It’s a common misconception that because an interchangeable biosimilar is a biosimilar that meets additional statutory requirements, it’s safer or more effective than a non-interchangeable biosimilar. However, both biosimilars and interchangeable biosimilars can be used in the place of a reference product and are considered as safe and effective as the reference product. Accumulated experience regarding biosimilars indicates that biosimilars and interchangeable biosimilars have the same safety and effectiveness.All biosimilars give patients more treatment options.
Similar to generic drugs, biosimilars and interchangeable biosimilars introduce more medication options for patients and may cost less because their manufacturers rely on FDA’s finding that the original biologics are safe and effective to abbreviate their drug development programs. The potential lower cost is not a reflection of the effectiveness or safety of biosimilars.FDA is in the process of updating its guidance to the pharmaceutical industry on interchangeable biosimilars to recommend fewer tests to demonstrate interchangeability.
Cumulative experience with biosimilars has shown that the risks of switching between the reference product and a biosimilar is insignificant. The updated recommendations in this guidance, when finalized, are intended to create a framework for faster interchangeable approvals without compromising FDA’s high standards for safety and effectiveness.Biosimilars and interchangeable biosimilars have had a positive impact on public health.
Nearly a decade after the first U.S. biosimilar approval in 2015, biosimilars and interchangeable biosimilars have had a significant impact on improving health outcomes and treating various medical conditions. Collectively, patients have used biosimilars for almost 700 million days of therapy, 344 million days of which patients received care they otherwise may not have received without biosimilar competition. Their impact reaches beyond savings to the health care system, by increasing health equity, and could help improve patients’ access to medications that previously may not have been covered by their insurance or were otherwise unaffordable.Use FDA’s Purple Book Database of Licensed Biological Products to find out if your medication has an approved biosimilar.
The Purple Book Database of Licensed Biological Products is a searchable database of FDA-approved (also described as “licensed”) biological products, including licensed biosimilar and interchangeable products, and their reference products. The Purple Book has many features to meet the needs of a variety of users. This includes simple and advanced search options, a glossary of terms, links to product labels, and the ability to search, filter, and sort information depending on the needs of the user. The database is designed for the public, health care professionals, researchers, and manufacturers to have a comprehensive reference tool at their disposal for biological products, including biosimilars and interchangeable biosimilars.Visit FDA's Biosimilars page to access educational materials on biosimilars.
FDA’s biosimilars website has many resources for patients and health care professionals to learn more about biosimilars. There are fact sheets, videos and infographics for patients and health care professionals and many of them are translated into multiple languages. On this site, you can also access a curriculum toolkit for health care degree programs that provides more in-depth information on a variety of topics related to biosimilars. Free Medscape courses are also linked from the multimedia education materials page.
