Generic drug development differs from new-drug development mainly in its development objectives and regulatory requirements. In generic drug development, the goal is to develop a product that is comparable to an already approved reference medicine in terms of quality, safety, performance, and, where required, bioequivalence. The development of generic drugs can therefore follow a different regulatory pathway and may require less extensive clinical data than new-drug development, depending on the product and applicable regulations. Factors such as formulation complexity, dosage form, API characteristics, regulatory requirements, and bioequivalence expectations still influence the generic drug development timeline. Overall, new-drug development is centered on establishing a new medicine, while generic drug product development is focused on developing a comparable version of an existing approved medicine that meets the required quality and performance standards.