Drugs

Information for Consumers (Biosimilars)

Biological Products

Many of today’s important medications are biological products. Biological products are made from living organisms. The material they are made from can come from many sources, including humans, animals and microorganisms such as bacteria or yeast. Biological products are manufactured through biotechnology, derived from natural sources or, in some cases, produced synthetically.

Biological products are among the medications used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer. 

Most biological products are more complex in structure and have larger molecules or mixtures of molecules than conventional drugs (also called small molecule drugs). Conventional drugs are made of pure chemical substances and their structures can be identified.  Most biologics, however, are complex mixtures that are more difficult to identify or characterize.

What are biosimilar and interchangeable biological products?

There are two new types of biological products- biosimilar and interchangeable. Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.

An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient.

Will biosimilars and interchangeables work in the same way as the biological reference product they were compared to?

Yes, biosimilars have no clinically meaningful differences in terms of safety and effectiveness from the reference product they were compared to.  In addition, a biosimilar needs to have the same mechanism of action as the reference product it was compared to, which means it will work in the same way as the reference product.

The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product. Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product.

An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient, and for a product that is given to a patient more than once, the risk in terms of safety and effectiveness of alternating or switching between the interchangeable and the reference product is not greater than the risk of using the reference product without alternating or switching.

Once a biosimilar or interchangeable has been approved by FDA, patients and health care providers will be able to rely upon the safety and effectiveness of an FDA approved biosimilar just as they would for the reference product that the biosimilar was compared to.

How are biosimilars and interchangeables prescribed?

A biosimilar product can be prescribed by a health care provider in place of the FDA-approved reference product. The health care professional has to write the specific name of the product on the prescription if they want to prescribe the biosimilar.

An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product. That means the patient may receive the interchangeable instead of the reference product, even if the health care provider writes the prescription for the reference product.  

If you are prescribed a biosimilar or interchangeable product, it will work in the same way (i.e., same mechanism of action) as the reference product.

Are biosimilars generic versions of biological products?

No, generic drugs are copies of brand-name drugs, have the same active ingredient, and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. That means the brand-name and the generic are bioequivalent.  Biosimilars are highly similar to the reference product they were compared to, but have allowable differences because they are made from living organisms. Biosimilars also have no clinically meaningful differences in terms of safety, purity, and potency from the reference product.

For additional information on generic drugs, please go to “What are Generic Drugs?

How are biosimilars approved?

Biosimilars were created under the Biologicals Price Competition and Innovation Act (BCPI) of 2009 and signed into law through The Patient Protection and Affordable Care Act (Affordable Care Act) on March 23, 2010. The BCPI Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product.

Under this law, a biological product may be demonstrated to be biosimilar if data show that, among other things, the product is highly similar to an already-approved biological product, also called the reference product, and has no clinically meaningful differences in terms of safety, purity, and potency from the reference product. Therefore, the biosimilar approval relies on the agency’s previous findings that the FDA-approved reference product is safe and effective.

How does the Agency Determine Biosimilarity or Interchangeability?

The manufacturer must submit an application for a biosimilar or interchangeable biological product that includes, among other things, information demonstrating biosimilarity based upon data from analytical studies, animal studies, and clinical studies such as the assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD).

If the manufacturer wants its product to be reviewed as an interchangeable product, the application must also include data or information to show that the proposed interchangeable product is expected to produce the same clinical result as the reference product in any given patient. In addition, when a product will be administered more than once to an individual (as many biological products are), the manufacturer must also demonstrate that the risk in terms of safety or reduced effectiveness of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without alternating or switching. This is in addition to the data described above to demonstrate biosimilarity.

Additionally, the facilities where biosimilars are manufactured must meet the FDA’s standards.

Page Last Updated: 03/06/2015
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