Are generic medicines too easy to develop?
Manufacturers are not required to re-investigate the efficacy and safety of the active ingredient used in generic medicines as this has already been done in conjunction with the development of the original reference medicine. When the innovator company’s period of exclusivity ends, others can utilise the information without the need to carry out unnecessary duplicate clinical trials. This speeds up the development of generic medicines and makes the process more cost-effective.
The generic medicine itself must be developed using the same methods and is subject to the same documentation requirements as the original reference medicine. All relevant information regarding the product development and manufacturing process and quality assurance methods as well as comparative studies on absorption (so-called bioavailability) must be provided in conjunction with a marketing authorisation application. The development of a generic medicine requires significant pharmaceutical and medical expertise.