Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

Biosimilars: What Patients with Diabetes Need to Know
Biosimilars are a type of biologic medication that is safe and effective
for treating diabetes and many other chronic and severe conditions, including:
• Chronic skin and bowel diseases
• Arthritis
• Kidney conditions
• Some cancers

What are biologic medications?
Most biologics, including insulin, are made from living sources, such as animal cells and
microorganisms like bacteria or yeast, including insulin. Because they come from living sources
and have natural differences, biologics are more complicated to produce than drugs made from
chemicals. Drugs made from chemicals, such as aspirin, can easily be 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 medication 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 will allow 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) already approved by FDA. Studies have shown that there are no differences in
the safety and effectiveness of biosimilars and the original biologics. Compared with original
biologics, biosimilars:
• Provide the same benefits when treating disease
• Are given at the same strength and dosage
• Cause no new or worsening side effects
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.

For more information on biosimilars, visit

www.FDA.gov/biosimilars
and talk to your doctor to learn more.

Biosimilars: What Patients with
Diabetes Need to Know (continued)

Why aren’t biosimilars identical to the original biologics?
Because all biologics are made from living sources, it is normal for there to be 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 in the original biologic and the biosimilar to ensure that
biosimilars are safe and effective, just as the original biologics are.

All biologic medications, including biosimilars, are similar to loaves
of bread made using the same recipe. No one loaf is an exact copy
of another, but all are the same type of bread. The same is true for
biologics, because they are made from a mix of ingredients that include
living sources, so they are not exact copies but provide the same
treatment benefits.

Biosimilars may be available at a lower cost than the original biologics are. Similar to
generic drugs, biosimilars cost less because manufacturers use existing research that led to
the development of the original biologics. The lower cost is not a reflection of the effectiveness
of biosimilars. Because of the lower cost, these medications may be covered by more insurance
companies and offer additional treatment options for patients.

How will this change affect an insulin prescription for me or a person I care for?
The regulation of insulin as a biologic will have no impact on your ability to fill current prescriptions
through a pharmacist. The physical appearance of the insulin and how you administer it will also
stay the same. There may be small changes to the labeling on the packaging and vial over time.
The most noticeable change is that patients can be prescribed a variety of new insulin treatment
options once they are available, possibly at lower cost, depending on your insurance coverage.

For more information on biosimilars, visit

www.FDA.gov/biosimilars
and talk to your doctor to learn more.

Biosimilars: What Patients with
Diabetes Need to Know (continued)

Biosimilars are safe and effective. As it does with all medication approvals, FDA takes a number
of steps to ensure that all biosimilars, including insulin, are ready 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 ensure the safety and effectiveness of biosimilars as it does for all
medications.
Before approving a biosimilar, FDA:
• 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 and that the side
effects of the biosimilar are not more frequent or more severe than those of the original biologic
After approval, FDA:
• Checks the quality of the biosimilar during the production process
• Reviews reports from patients and health care providers on safety and effectiveness
As with all treatment decisions, patients should talk to their doctors and check other trusted sources
of information related to their specific condition to learn more about biosimilar treatment options.
Biosimilars are a growing field of life-changing 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 are also
available for doctors and patients on the FDA website, www.fda.gov/biosimilars.

For more information on biosimilars, visit

www.FDA.gov/biosimilars
and talk to your doctor to learn more.

Biosimilars: What Patients with
Diabetes Need to Know (continued)

Analogy Alternative for Biosimilars/Biologics
All biologic medications, including biosimilars, are like oranges: No one
orange can be an exact copy of another, because it came from a living
organism, but they are all oranges. The same is true for biologics and
biosimilars. They are made from living sources and are not exact copies,
but they provide the same treatment benefits.

For more information on biosimilars, visit

www.FDA.gov/biosimilars
and talk to your doctor to learn more.