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:
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:
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:
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: