Overview for Health Care Professionals (original) (raw)
Biosimilars approved by the FDA are safe and effective biological medications. The availability of biosimilars can provide patients with more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
Learn more about biological products, including biosimilars and interchangeable biosimilars:
- [What is a biological product?](#What is a biological product)
- [What is a biosimilar product?](#What is a biosimilar product)
- [Are biosimilars the same as generic drugs?](#Are biosimilars the same as generic drugs)
- [How does FDA review and approve biosimilars?](#How does FDA review and approve biosimilars)
- [What is the difference between a biosimilar and an interchangeable biosimilar?](#What is the difference between a biosimilar and an interchangeable biosimilar)
What is a biological product?
- Biological products, or biologics, are used to treat many illnesses, including chronic skin diseases, such as psoriasis; inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis; arthritis; kidney conditions; diabetes; and cancer.
- Biologics are generally large, complex molecules that are made from living sources such as bacteria, yeast, and animal cells.
- Because they generally come from living organisms, biologics inherently contain many slight variations from batch to batch, and their structures are generally more complex than those of other medications. As a result, biologics are often more complicated to purify, process, and manufacture.
- There are many types of biologics approved for use in the United States, such as monoclonal antibodies, insulin, vaccines, and allergenic products.
Biosimilar Basics for Patients
Find useful information on biologics and biosimilars for patients.
What is a biosimilar product?
A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product.
- Compared with a reference product, biosimilars:
- Are made with the same types of living sources
- Are given to the patient in the same way
- Have the same strength, dosage, potential treatment benefits, and potential side effects
- A biosimilar may be used in patients who have previously been treated with the reference product (treatment-experienced), as well as in patients who have not previously received the reference product (treatment-naïve).
What Is a Biosimilar?
View and download our infographic on biologics and biosimilars.
Are biosimilars the same as generic drugs?
- Biosimilars are like generic drugs in some ways, because both are versions of brand-name drugs and may offer patients more affordable treatment options.
- The main difference between biosimilars and generic drugs is that the active ingredients of generic drugs are generally smaller, simpler, and more straightforward to copy.
- Biologics generally cannot be copied exactly, because the products usually contain a mix of many slight variations of a protein, and this mix is never exactly the same in each dose or batch of the product.
How does FDA review and approve biosimilars?
All FDA-approved biologics undergo a rigorous evaluation to help ensure their safety, effectiveness, and quality:
- A reference product is approved in a stand-alone application that must contain data to demonstrate its safety and effectiveness, while a biosimilar is approved through an abbreviated pathway that generally avoids the need to conduct as many costly and lengthy clinical trials.
- A proposed biosimilar is compared to and evaluated against a reference product to verify that it is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the reference product.
The biosimilar approval process provides assurance that biosimilars provide the same treatment benefits and risks as their respective reference products. Learn more about the biosimilar regulatory review and approval process.
What is the difference between a biosimilar and an interchangeable biosimilar?
All FDA-approved biosimilars, including interchangeable biosimilars, must be highly similar to and have no clinically meaningful differences from the reference product in terms of safety and effectiveness. An interchangeable biosimilar is a biosimilar that meets additional requirements. A pharmacist may substitute an interchangeable biosimilar for its reference product without consulting the prescriber, depending on state pharmacy laws. FDA does not evaluate or approve a biosimilar as interchangeable unless a company requests it. Learn more about interchangeable biological products.
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
FDA has released its updated labeling guidance for biosimilar and interchangeable biosimilar products to include a “biosimilarity statement.” Learn more about this update from Sarah Yim, M.D., Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars.