Are you on a

biologic medication?

The U.S. Food and Drug Administration (FDA) has approved many biologics (also 

called biological products), which are medications generally made from living sources 

like bacteria and yeast. Biologics treat many conditions like arthritis, diabetes, kidney 

conditions, cancer, macular degeneration, and chronic skin and bowel diseases, such as 

psoriasis, Crohn’s disease, and ulcerative colitis. 

But biologics are often expensive and can be unaffordable, especially for people using 

several medications. If you’re currently using a biologic and you’re concerned about 

cost, you and your health care provider may want to talk about switching to a biosimilar. 

A biosimilar is an FDA-approved biologic that is highly similar to and has no clinically 

meaningful differences from a biologic previously approved by FDA, which is sometimes 

described as the original biologic or reference product. Like generic drugs, biosimilars 

may save you money and are as safe and effective as the original biologic.

Some patients and health care providers might worry that biosimilars are not as safe 

or effective as the original biologic or that an interchangeable biosimilar is better than 

a biosimilar that is not an interchangeable biosimilar. Unwarranted concerns may 

discourage patients and their doctors from using or switching to a biosimilar, so it’s 

important to find out the facts. 

How is a biologic like other drugs? 

FDA-approved biologics, like other drugs FDA approves, are safe and effective 

medications for treating many illnesses. However, biologics are usually made from living 

sources such as proteins, living cells, and microorganisms such as bacteria or yeast. 

They usually are more complex than other drugs, and more complicated to make. 

For more information on biosimilars, visit www.FDA.gov/biosimilars and talk to your doctor to learn more.

What you need to know about 

biosimilar treatment options.
What is a biosimilar?

A biosimilar is a biologic that is highly similar to an original biologic already approved 

by FDA. Both products are made from the same types of sources (such as living cells or 

microorganisms). Biosimilars also have no clinically meaningful differences from original 

biologic. This means biosimilars are as safe and effective as the original biologic 

for their approved uses.

Is a biosimilar the same as a generic?

Biosimilars and generics are a lot alike. For example, both are versions of FDA-approved 

medicines and both may offer patients more affordable treatment options. Both also go 

through a rigorous review process at FDA. Once FDA approves biosimilars and generics, 

patients and their doctors can be confident that they are just as safe and effective as the 

products they’re compared to. 

There are also some differences between biosimilars and generics. Generics can be 

easier to copy exactly because their active ingredients tend to be smaller and simpler. 

Meanwhile, biologics generally cannot be copied exactly, even between batches of the 

same brand, because their living sources can contain many slight variations. However, 

FDA requires biologic manufacturers, including biosimilar manufacturers, to carefully 

control and monitor for differences.

Should I be concerned if my doctor prescribes a biosimilar or wants 

to switch me from a reference product to a biosimilar?

No. FDA-approved biosimilars are as safe and effective as their original biologic and you 

can expect biosimilars to have the same benefits and risks as the original biologic. To 

be approved by FDA, companies show that patients on biosimilars don’t have any new or 

worsening side effects as compared to patients on the original biologic. 

Your doctor may prescribe or switch you to a biosimilar for any number of reasons, 

including because it may be less costly, or the biosimilar might be covered by your 

insurance company. 

Are you on a biologic medication? What you need to know about biosimilar treatment options. (continued)

For more information on biosimilars, visit www.FDA.gov/biosimilars and talk to your doctor to learn more.
Are you on a biologic medication? What you need to know about biosimilar treatment options. (continued)

What is the difference between a biosimilar and an interchangeable 

biosimilar?

Biosimilars and interchangeable biosimilars both must meet FDA’s requirements for 

showing that they are highly similar to and have no clinically meaningful differences from 

a biologic already approved by FDA. The difference is that an interchangeable biosimilar 

meets additional requirements related to the potential for “pharmacy level substitution.” 

This means a pharmacy may substitute an interchangeable biosimilar for the reference 

product without consulting the prescribing doctor, depending on state pharmacy laws. 

Should I wait for a biosimilar to be approved as “interchangeable” to use it?

No. Both biosimilars and interchangeable biosimilars meet the same high standard of 

biosimilarity for FDA approval and both are as safe and effective as the original biologic. 

Moreover, many biosimilar manufacturers do not seek “interchangeable” status because 

interchangeability is only relevant to pharmacy-level substitution, which depends on state 

pharmacy laws. Biosimilars and interchangeable biosimilars can both be used in place of 

the original biologic.

Will biosimilars cost less? Will my insurance cover it? 

FDA does not have a direct role in drug pricing, but FDA’s work does play a critical role 

in increasing access to safe and effective biologics and supporting a competitive 

marketplace for biologics. Biosimilars may improve patient access to medicines and 

lower health care costs. 

Insurance coverage and reimbursement can affect patient and doctor adoption of 

biosimilars. In turn, such coverage and reimbursement can depend on many factors, 

such as insurance plans and formulary coverage. If you have insurance, check with 

your insurance provider to find out what’s included in your plan. If you are covered by 

Medicare or Medicaid, check with the Centers for Medicare & Medicaid Services

(https://www.cms.gov) and your plan provider.

For more information on biosimilars, visit www.FDA.gov/biosimilars and talk to your doctor to learn more.
Are you on a biologic medication? What you need to know about biosimilar treatment options. (continued)

For More Information

Visit www.fda.gov/biosimilars and talk to your doctor about available treatment options 

and potential risks and benefits.

To Report False or Misleading Advertising to FDA and Federal Trade 

Commission (FTC)

Contact the FDA Bad Ad program (https://www.fda.gov/drugs/office-prescription-drugpromotion/bad-ad-program) and FTC (https://www.ftc.gov/complaint) to report false or 

misleading prescription drug advertising, including advertising for biological products. 

You can also report false or misleading non-prescription or other health product or 

service advertising to FTC (https://www.ftc.gov/complaint).

Additional Advice

Contact your state Attorney General’s office (https://www.naag.org/find-my-ag/), your 

state department of health, or your local consumer protection agency 

(https://www.usa.gov/state-consumer) to seek additional consumer advice.  

For more information on biosimilars, visit www.FDA.gov/biosimilars and talk to your doctor to learn more.