Clinical Trials for Generics

Generics are the drugs produced and distributed with an active ingredient that has lost patent protection. What makes generics attractive is the lower cost and ability to piggy back on research done 20 years back. This post is not about the merits and demerits of generics but will focus on clinical trials and regulation needed to get generics into market.

For SMALL MOLECULES the only additional clinical evaluation to be done is bioequivalence (or to show that the pharmacokinetics and dynamics of the generic compound are same as the original compound. 

The regulatory position on Generics has been positive, and they are taking measures to ensure increasing approval of generics.

1. U.S. generics approval process enacted in 1984, the U.S. Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act", standardized U.S. procedures for recognition of generic drugs. 
2. An applicant files an Abbreviated New Drug Application (or "ANDA") with the Food and Drug Administration (FDA) and seeks to demonstrate therapeutic equivalence to a specified, previously approved "reference listed drug." 
3. When an ANDA is approved, the FDA adds the drug to its Approved Drug Products list, also known as the "Orange Book", and annotates the list to show equivalence between the reference listed drug and the approved generic. 
4. The FDA also recognizes drugs using the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. 
5. Recently FDA launched the Generic Initiative for Value and Efficiency, or GIVE. 
6. GIVE aims to increase the number and variety of generic drug products available. 
7. There has also been a "Critical Path Initiative for Generics" to accelerate the approval process via FDA.

For BIOLOGICS the story is different, globally regulatory organizations are pushing towards a comprehensive clinical trial program to ensure appropriate safety and efficacy of biologic generics.

There are number of CROs who offer bioequivalence services, and very few top end full service CROs such as Parexel, ICON and Quintiles who can handle the clinical trials for biologic generics. If you have a choice between patented vs generic drug research choose generics for now, lot of activity in that domain.