Whitepaper: Complex Generic APIs: A Primer

The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.

This very definition entails that the commercial versions of these products are challenging to replicate, which means limited competition and potentially great economic rewards.

Even though the US FDA is approving more and more of these applications, the truth is that they require multiple cycles of revisions, leading to potential delays in the realization of these economic promises and, more often than not, additional costs. For some of these complex generics, the difficulty lies with the demonstration of the analytical and biological sameness of the API. Defining the best analytical approach and navigating the many hurdles linked to these complex generics is not a trivial task and needs careful and strategic planning.

EXECUTIVE SUMMARY

The potential for economic reward associated with the development of complex generic medicines means there has been dramatic growth in the sector in recent years.