and talk to your doctor to learn more.

For more information on biosimilars, visit

www.FDA.gov/biosimilars

Biosimilars:

Biosimilars are a type of biologic medication 

that is safe and effective for the treatment of 

many chronic and severe conditions, including:

A biosimilar is very similar, but not identical, to an original 

biologic medication (also known as a reference product) that 

FDA has already approved. For biosimilars to be approved by FDA, 

studies must show that there are no differences in the safety and 

effectiveness of biosimilars and the original biologics.

Both a biosimilar and its original biologic:

• Are made from the same types of sources (e.g., living sources)

• Provide the same benefits when treating diseases or medical

conditions

• Are given at the same strength and dosage

• Are not expected to cause new or worsening side effects

FDA has approved many biosimilars and expects to approve more in 

the future. For more information about individual biosimilars and the 

conditions they treat, please visit https://purplebooksearch.fda.gov.

What are biologic 

medications? How are they 

different from other types 

of medications?

Most biologics are made from 

living sources, such as animal 

cells and microorganisms like 

bacteria or yeast. Because 

biologics generally come from 

living sources and have natural 

differences, they can be more 

complicated to produce than 

drugs made from chemicals. 

Drugs made from chemicals, 

such as aspirin, can generally 

be more easily copied.

What Patients Need To Know

Arthritis

Kidney 

conditions

Some cancers

(such as breast, lung, 

and colon)

Macular 

Degeneration

What are interchangeable 

biosimilars?

An interchangeable product is a 

biosimilar that may be substituted 

without consulting the prescribing 

doctor, because it meets additional 

requirements related to the 

potential for automatic substitution. 

This practice is called “pharmacylevel substitution” and is subject to 

state law.

Both biosimilars and 

interchangeable biosimilars are as 

safe and effective as the original 

product they were compared to.

Chronic skin 

diseases

(such as psoriasis)

Chronic bowel 

diseases

(such as colitis, Crohn’s 

disease, and irritable 

bowel disorder)

Diabetes

Multiple 

Sclerosis
Biosimilars: What Patients Need To Know (continued)

and talk to your doctor to learn more.

For more information on biosimilars, visit

www.FDA.gov/biosimilars

Why aren’t biosimilars 

identical to the original 

biologics?

Because most biologics are made 

from living sources, it is normal 

for both biosimilars and original 

biologics to have minor differences 

between batches of the same 

medication. This means that 

biologics cannot be copied exactly, 

and that is why biosimilars are not 

identical to the original biologic.

FDA carefully reviews the 

differences between the original 

biologic and the biosimilar to 

ensure that biosimilars are as 

safe and effective as the original 

biologics.

Similar to generic 

drugs, biosimilars 

may cost less because 

manufacturers rely 

on FDA’s finding that 

the original biologics 

are safe and effective. 

The lower cost is not 

a reflection of the 

effectiveness or safety 

of biosimilars.

All biologic medications, including biosimilars, 

are similar to loaves of bread if they were made 

with the same recipe: No one loaf is an exact 

copy of another, but they are all the same type 

of bread. The same is true for biologics: Each 

batch of a biologic medication is made with a mix of 

ingredients that include living sources. Because living sources 

have slight variations, each batch is not an exact copy, but each batch 

provides the same treatment benefits.

Are biosimilars the same as generic drugs?

Biosimilars and generics are both versions of medications already 

approved by FDA. Biosimilars are like generics in some ways, but 

there are differences. Both biosimilars and generics may offer more 

affordable treatment options to more patients.

Biosimilars Generics

Generally made from living sources

Require a specialized process

to produce

Very similar, but not identical,

to original biologics

Faster development process using 

public information from original 

biologic approval

Usually less expensive than 

original biologics

Generally made from chemicals

Have a simpler process to copy

Copy of brand-name drugs

Faster development process 

using public information from 

brand-name drug approval

Usually less expensive than 

brand-name drugs

Biosimilars may be available at a lower cost than the original 

biologics. Similar to generic drugs, biosimilars may cost less because 

manufacturers rely on FDA’s finding that the original biologics are 

safe and effective. The lower cost is not a reflection of the safety or 

effectiveness of biosimilars. Because of the lower cost, biosimilars 

may be covered by more insurance companies and offer patients 

additional treatment options.
Biosimilars are safe and effective. As it does with all medication 

approvals, FDA carefully reviews the data provided by pharmaceutical 

companies and takes a number of steps to ensure that all biosimilars 

meet standards for patient use. Patients and health care providers 

can rely on a biosimilar to be as safe and effective as the original 

biologic. FDA takes the same precautions to help ensure the safety 

and effectiveness of biosimilars as it does for all medications.

As with all treatment decisions, you should talk to your health care 

providers and check other trusted sources of information related to your 

specific condition to learn more about biosimilar treatment options.

Biosimilars are a growing field of critical treatment options for a range 

of conditions. FDA is committed to educating patients and caregivers 

about biosimilars so they understand all potential treatment options. 

More detailed information on the approval process and published 

studies is available for doctors and patients on the FDA biosimilars 

website, www.fda.gov/biosimilars.

Why would a patient 

switch from an 

original biologic to a 

biosimilar?

A biosimilar is not safer or 

more effective than the original 

biologic, but a patient might 

switch to a biosimilar because of 

a change in insurance coverage 

or to save money. Depending 

on the law in your state, a 

pharmacist may give you an 

interchangeable biosimilar, 

much like they would give you 

a generic. FDA does not control 

the cost of drugs, but you can 

learn more about the price 

of a specific biosimilar by 

contacting your pharmacy or 

insurance company.

and talk to your doctor to learn more.

For more information on biosimilars, visit

www.FDA.gov/biosimilars

Biosimilars: What Patients Need To Know (continued)

Carefully reviews data, 

studies, and tests to decide 

whether a biosimilar meets 

FDA’s high standards for 

approval

Ensures that manufacturers show that 

there are no differences in side effects, 

including that the side effects of the 

biosimilar are not more frequent or more 

severe than those of the original biologic

Before approving a biosimilar, FDA:

Continues to check on the 

quality of the biosimilar 

production

Reviews reports from patients and health 

care providers on the biosimilar’s safety 

and effectiveness

After approval, FDA: