### Question
How does the law define biosimilar biological product development program?


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

> the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development

#### 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**

