ABSTRACT
An interchangeable biological product is biosimilar to a Food and Drug Administration (FDA)-licensed reference product and meets additional standards for interchange ability. The FDA requires licensed biosimilar and interchangeable biological products to meet the FDA's rigorous standards of safety and efficacy. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the healthcare provider who prescribed the reference product. Extrapolation refers to the allowance of all indications licensed or a limited number of multiple indications licensed for the use of the originator product. When developing biosimilar products, the identification is further narrowed by the fingerprint provided by the originator product; the sponsor needs to replicate all attributes, components, and even in some cases impurities. Biosimilar biological products, a category of their own, have a great potential, as every biological product is subject to being developed as a biosimilar product.
