Biosimilars

Biosimilars

A biosimilar product is an FDA-approved biologic product that has been shown to be remarkably similar to another FDA-approved biologic product, also known as a reference product, and to differ from the reference product in neither safety nor efficacy in any clinically relevant ways.  Biosimilar goods can only have very small variations in therapeutically inactive components. In terms of safety, purity, and potency, biosimilars are quite comparable to the reference product, however there may be small changes components that are clinically inactive. Recombinant DNA technology is used to create biosimilars in live organisms, as opposed to the generic drugs, chemical synthesis is necessary. The production of biosimilars is more difficult than that of conventional small molecules. Generics primarily because biosimilars have bigger, more intricate molecules