### Question
How does FEDERAL FOOD, DRUG, AND COSMETIC ACT define process for the review of biosimilar biological product applications?


### Answer
Under *21 U.S.C. § 379j*, **process for the review of biosimilar biological product applications** is defined as:

> the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:


(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements

#### 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**

