Biosimilars PDF Resource Summary
What is a Biosimilar?
Helpful information from the FDA explaining what a biosimilar is.
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:
Large and generally complex molecules
Produced from living organisms
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:
Purity
Molecular Structure
Bioactivity
The data from these comparisons must show that the biosimilar is highly similar to the reference product.
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 (effectiveness) compared to the reference product:
Pharmacokinetic and, if needed, pharmacodynamic studies
Immunogenicity studies
Additional clinical studies as needed
A biosimilar is approved by FDA after rigorous evaluation and testing by the applicant
Prescribers and patients can feel confident about using these medications instead of reference products because biosimilars:
Meet FDA’s rigorous standards for approval
Are manufactured in FDA-licensed facilities
Are tracked as part of post-market surveillance to ensure continued safety
Additional Biosimilars Resources
FDA
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards.
Biosimilars Forum
Providing evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars.
