5. Elements of QbD in a Drug Application of a Branded Generic – the First Steps at Pharma Example Ltd.

The following case study example describes the approach to adopt the paradigm shift of a QbD driven development for the development of branded generics, that is drug products of a generic drug compound marketed under their own brand. Through formulation, dosage form or drug delivery technology they often provide a further benefit for the patient, while normal generics simply copy the formulation of the innovator’s product as good as possible after that has lost its exclusivity. Therefore, branded generics do require more development activities and also run a higher risk of failure than other generics. However they also gain marketing approval by demonstrating bioequivalence to the originator’s product. In order to improve development success for these products the objective has to be speeding up overall development timelines in order to file as quickly as possible after expiry of the innovator’s patent protection on the drug compound.