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

Biosimilar Basics
Biosimilars are a type of biologic
medication that is safe and effective
for treating many illnesses, such
as chronic skin and bowel diseases,
arthritis, diabetes, kidney conditions,
and some cancers.

Most biologic medications are made from 
living sources (such as animal cells), developed
using advanced science, and given via injection.
Biosimilars are FDA-approved medications
that are very similar, but not identical, to
another medication — the original biologic.

Biosimilar &
Original Biologic
Same benefits
Same potential
side effects
Same strength
and dosage
Given the same way

A biosimilar and its original biologic are
made from the same types of sources —
and provide the same treatment risks
and benefits.

Biosimilars can be made by multiple companies — similar to generics.
Biosimilars are like generics in some ways but different in others.

Biosimilars

Generics

Made from living sources

Made from chemicals
Generics

Biosimilars

Require a specialized process
to produce

Have a simpler process to copy

Very similar, but not identical,
to original biologics

Copy of brand name drugs

Less expensive than
original biologics

Less expensive than 
brand name drugs

Biosimilars can provide patients
with more access to important
treatments and an opportunity
to save money.

Biosimilars
are approved
by FDA after a
careful review of
data, studies, and tests.

More options

Lower costs

FDA monitors the safety and
effectiveness of all medications
after their approval.
Check for medication quality
during production

Review patient safety reports

To learn more, visit

www.FDA.gov/biosimilars