Abstract

BIOLOGICAL LICENSING APPLICATION VS DRUG LICENSING APPLICATION: COMPARISONS AND CONSEQUENCES

Sudheep Goud Sandhil, AfrasimMoin*, Jophy Johnson

ABSTRACT

The advancement in the medical sciences has led to the innovation of novel and complex formulations which includes unique combinations of drugs and biologics. The FDA has separate review process for a new drug and a biological product.Given these differences between the review processes for a new drug and biologic product, the designation of a combination drug as a drug or biologic product has often become critical. To avoid confusions in the review and designation process of a combination product, FDA has promulgated various guidelines assigning certain product classes to CDER or CBER and three intercenter agreements were made in the process. However, the FDA’s guidelines are not exhaustive and at times an individual designation is to be obtained from the office of communication products by submitting a Request for Designation (RFD). The RFD process is based on the Primary Mode of Action (PMOA), and the FDA provides ample guidance in how to determine the PMOA. This review article deals initially with an overview of approval process for a drug and a biologic product followed by comparisons of the same.This study aims at describing the methods followed by the FDA in designation process of a combination drug and also to list the alternative step of applying RFD for a combination product.Finally it concludes with the description of factors that influence the designation process of a combination drug with illustration of few examples.

Keywords: FDA, CDER,RFD, PMOA, Combination Product.