and talk to your doctor to learn more.

For more information on biosimilars, visit

www.FDA.gov/biosimilars

Biosimilars:

Biosimilars are types of biologic medications 

that are safe and effective for treating many 

chronic and severe conditions, including 

diabetes, as well as: 

What are biologic 

medications? How are 

they different from other 

types of medications? 

Most biologics, including 

insulin, 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.

Has insulin always been 

a biologic? 

Although insulin is made in 

living cells, it was historically 

regulated as a drug made from 

chemicals. Insulin and other 

drugs that meet the criteria for 

a biologic are now regulated as 

biologics. This does not change 

the ingredients of insulin or 

how you obtain medication at 

the pharmacy.

The regulation of insulin as a biologic allows multiple companies 

to make biosimilar versions of “brand name” insulins, similar to 

how generics are versions of brand name drugs. 

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

(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 

their 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

What Patients With Diabetes Need To Know

Arthritis

Kidney 

conditions

Some cancers

(such as breast, lung, 

and colon)

Macular 

Degeneration

Chronic skin 

diseases

(such as psoriasis)

Chronic bowel 

diseases

(such as colitis, Crohn’s 

disease, and irritable 

bowel disorder)

Diabetes

Multiple 

Sclerosis
FDA has approved many biosimilars and expects to approve more 

in the future. For more information about individual biosimilars, 

including insulin, and the conditions they treat, please visit 

https://purplebooksearch.fda.gov.

All biologic medications, including biosimilars, 

are similar to loaves of bread if they were made 

using 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 

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.

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 effectiveness or 

safety 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, 

including insulin, 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.

Biosimilars: What Patients With Diabetes Need To Know (continued)

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 

“pharmacy-level 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.

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 their original biologics. 

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.
 

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.

How will the availability 

of biosimilar insulins 

affect me or a person 

I care for? 

The most noticeable change is 

that patients can be prescribed 

a variety of additional insulin 

options once they are available, 

possibly at a lower cost, 

depending on your insurance 

coverage. Depending on the 

state law, a pharmacist may 

give you an interchangeable 

biosimilar insulin, much like they 

would substitute a generic for 

a brand-name drug. 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.

For more information on biosimilars, visit

www.FDA.gov/biosimilars

and talk to your doctor to learn more.

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:

Biosimilars: What Patients With Diabetes Need To Know (continued)