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.
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.
Related content from this organisation
- Quality driven solutions from discovery to commercialisation
- SGS experts help to mitigate the risk of nitrosamine impurities in drug products
- Guide to Outsourcing
- Article: Analytical Quality by Design (AQBD) approach to support analytics optimisation strategy
- SGS’s Centre of Excellence for Biosafety contributes to the fight against coronavirus