Do generic manufacturers have access to data of originator products?
A. No. Generic manufacturers conduct their own research and develop their own formulations as data of originator medicines are never revealed to third parties. However, generic producers can refer to published clinical data concerning the product’s safety and efficacy. Generic manufacturers do not need to repeat clinical trials as this is unnecessary and unethical. The reference product has been authorised for several years, therefore safety and efficacy data is already available.
