Biological products, derived from mammalian, bacterial, or from animal origins constitute many of todays importantmedications. As numerous patents protecting originator biological products are expiring, the development of Generics, Biologics products, biosimilars become a lucrative and exciting opportunity for many traditional generic and international pharmaceutical companies. Unlike small molecule drugs, generally targeted by the traditional generic industry, biological products are usually highly complex in structure.This presentation will highlight the differences between the regulation covering generic small molecule drugs and biosimilar-based drugs and focus on the regulatory challenges in implementing the new regulations. |
