Compared to the complexity of a new drug application, generic medicines should be a relatively simple application. However, in pharmaceuticals sometimes it is the small things which trip us up. Even specialist generic companies can experience difficulties in securing an approval for their generic application. This session will show the full spectrum of generics in Europe and their respective legal basis. It will walk through straightforward slam dunk applications; to applications where there are difficulties in demonstrating bioequivalence; to more complex applications involving multiple CMC changes compated to an originator product, such as a different dosage form. It will also discuss the EU legal basis for these abridged applications and cover regulatory difficulties such as correctly identifying a suitable reference product for your application. The session will also focus on common major objections raised by EU regulators on generic applications, as well as highlight potential cost and time savings where bioequivalence studies could be waived.
Learning Objectives:
Describe the legal basis and critical EMA guidance for generics in Europe
Explain the importance of biowaivers and how they are applied correctly in different circumstances
Verbalize the common major objections with EU generic applications and how they can be avoided