What is a BIOSIMILAR?

What is a Biosimilar: A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.

A biosimilar is a biological product

FDA-approved biosimilars have been compared to an FDA-approved biologic, known as the reference product. Reference and biosimilar products are:

What is a BIO SIMILAR?
Large and generally complex molecules
What is a BIO SIMILAR?
Produced from living organisms
What is a BIO SIMILAR?
Carefully monitored to ensure consistent quality

A biosimilar is highly similar to a reference product

For approval, the structure and function of an approved biosimilar were compared to a reference product, looking at key characteristics such as:

What is a BIO SIMILAR?
Purity
What is a BIO SIMILAR?
Molecular structure
What is a BIO SIMILAR?
Bioactivity

A biosimilar has no clinically meaningful differences from a reference product

Studies were performed to show that biosimilars have no clinically meaningful differences in safety, purity, or potency (safety and effectiveness) compared to the reference product:

What is a BIO SIMILAR?
Pharmacokinetic and, if needed, pharmaco dynamic studies
What is a BIO SIMILAR?
lmmunogenicity assessment
What is a BIO SIMILAR?
Additional clinical studies as needed

A biosimilar is approved by FDA after rigorous evaluation and testing by the applicant

Prescribers and patients should have no concerns about using these medications instead of reference products because biosimilars:

What is a BIO SIMILAR?
Meet FDA's rigorous standards for approval
What is a BIO SIMILAR?
Are manufactured in FDA-licensed facilities
What is a BIO SIMILAR?
Are tracked as part of post-market surveillance to ensure continued safety

Visit www.FDA.gov to learn more about biosimilars.