Are you up-to-date on complex generics? You probably already know they are inherently difficult to duplicate, yet still reviewed by CDER-OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs).
Complex generics represent an emerging market, largely because of the higher barriers to entry. Although akin to Biosimilars, the ANDA pathway is not always clear.
Hence, as with the development of biosimilars, complex generics require a substantial commitment of resources.
If you don’t have staff well-versed in their regulatory complexity, hiring a consultant who has experience with complex generics can make a substantial difference in managing resources, mitigating risks and developing methods to demonstrate sameness.
To read more about complex generics, click here.