It’s complicated: generics companies want FDA to simplify path for complex generics 

Stalemated applications for FDA approvals of generic versions of complex non-biologic drugs are sucking money out of the U.S. healthcare system, depleting resources that are needed to create headroom for spending on innovative drugs.

Complex generics are non-biologic drugs with a complex active ingredient, formulation or route of administration that makes it more difficult than a small molecule drug to determine bioequivalence with a reference product. ...