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

Biosimilars: What Patients Need to Know

Biosimilars are a type of biologic medication that is safe and effective
for the treatment of many chronic and severe conditions, including:
• Chronic skin and bowel diseases (such as colitis, Crohn’s disease, irritable bowel disorder,
and psoriasis)
• Diabetes
• Arthritis
• Kidney conditions
• Some cancers (such as breast, lung, and colon)

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 such as
bacteria or yeast. 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.

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 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 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 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.

Are biosimilars the same as generic drugs?
Biosimilars are like generics in some ways, but there are differences. Generics are drugs made
from chemicals, while biosimilars are made from living sources. Both are versions of medications
already approved by FDA that can be made by multiple companies. Therefore, both biosimilars
and generics have fewer requirements for approval, because they can rely on information from
the original product. Both biosimilars and generics may offer more affordable treatment options
to more patients.

Biosimilars may be available at a lower cost than the original biologics are. Similar to
generic drugs, biosimilars cost less because manufacturers used 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.

For more information on biosimilars, visit

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

Biosimilars: What Patients Need to Know (continued)

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 due to a change in insurance coverage or to save money.

Biosimilars are safe and effective. As it does with all medication approvals, FDA takes a number
of steps to ensure that all biosimilars 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 Need to Know (continued)

Analogy for Biosimilars/Biologics
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.

For more information on biosimilars, visit

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