### Question
What is the definition of biosimilar biological product?


### Answer
The definition of **biosimilar biological product** is as follows in *21 U.S.C. § 379j*:

> a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved

#### 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**

