Fujifilm Kyowa Kirin Biologics

Biosimilars are defined as "biomedical products that contain the active substance of an already authorized original biological product." The development of biosimilars cannot follow established generic regulatory pathways because biologics have extremely complex structures and characteristics, making it impossible to produce a molecule identical to the original biological product. Although biosimilar molecules are not completely identical to those of the original product, a high degree of similarity in quality attributes, biological activity, efficacy, and safety must be demonstrated for approval.