Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020

4 Facts About Biosimilars

Biosimilars are FDA-approved medications that are safe and effective
for the treatment of many conditions.
1. Biologic medications are generally made
from natural and living sources, such as
humans, animals, plants, bacteria, or yeast.
Because biologics come from natural sources, they
are usually more complex and are more complicated
to produce than drugs made from chemicals. Common
drugs, such as aspirin, are made from chemicals. The
Food and Drug Administration (FDA) has approved
several types of biologics to treat many illnesses, such
as chronic skin and bowel diseases, arthritis, kidney
conditions, and cancer.
2. A biosimilar is a type of biologic
medication that is compared to an original
biologic already approved by FDA (also known
as a reference product). A biosimilar is generally made
from the same type of natural sources as the original
biologic, provides the same benefits when treating
disease, is given at the same strength and dosage, and
causes no new or worsening side effects as the original
biologic. The terms “reference product” or “original
biologic” refer to the FDA-approved biologic that the
biosimilar is compared to. Studies have shown that
biosimilars have no major differences in their safety
and effectiveness compared to the original biologics.
Because all biologics, including biosimilars, are made
from living sources, it is normal for natural differences
between each batch of medication to occur during the
production process. This means that no biologic can
be an exact copy. Biosimilars are very similar, but not
identical, to the original biologics. FDA carefully reviews
the differences before approving biosimilars.

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3. An interchangeable medication is a
type of biosimilar that can be substituted
at the pharmacy. Like other biosimilars,
interchangeables could potentially lead to increased
access and lower costs for patients. Unlike typical
biosimilars, these medications may be used for the
treatment of chronic conditions at home instead of a
hospital, infusion center, or doctor’s office. As with
the substitution of brand name drugs for generics, the
ability to substitute without a prescription can help
lead to lower costs for patients. An interchangeable
is not safer or more effective than a biosimilar that
is not interchangeable. Rather, it simply means that
a company has taken additional efforts to meet the
standard for its proposed biosimilar to be made
interchangeable and has received approval from FDA.
4. Biosimilars, including interchangeables,
are safe and effective. FDA carefully
reviews data, studies, and tests to decide
whether a biosimilar meets the high standards for
approval. As it does with all medications, FDA checks
the quality of biosimilars during the production process
and reviews reports from patients and health care
providers on safety and effectiveness after approval.
But before biosimilars are approved, manufacturers
must show that the side effects are the same and are
no more frequent or severe than those of the original
biologic. Patients and health care providers can rely
on a biosimilar to be as safe and effective as the
original biologic.

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