Biosimilar

A biologic medication that is highly similar to an existing FDA-approved biologic, known as the reference product. Despite minor differences in clinically inactive components, a biosimilar has no clinically meaningful differences from the reference product in terms of safety, purity, and potency. Biosimilars are made from the same types of living sources and are administered in the same way, with the same dosage, strength, and potential side effects as the reference product.