### Question
How does FEDERAL FOOD, DRUG, AND COSMETIC ACT define biosimilar biological product application?


### Answer
Under *21 U.S.C. § 379j*, **biosimilar biological product application** is defined as:

> an application for licensure of a biological product under section 262(k) of title 42

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 8-fees relating to biosimilar biological products**

