Pharmaceutical consulting and generic drug professionals: What is your hedge against the increasingly crowded traditional drug markets?
As you probably know, many generic companies are turning to complex generics. However, complex generics are typically difficult to characterize and may require in-vitro, pharmacodynamic, clinical and post-market data to prove sameness.
As their name implies, it is generally difficult to establish an equivalency to the RLD (Reference Listed Drug). The bottom line is complex generic drugs require a substantial commitment of resources.
However, for applicants willing to take the risk and develop complex generics, the rewards can be great.
To read more of PDG’s article ‘Breaking Down Complex Generics’ click here.