Biosimilar biological product

Biosimilar biological product means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 351 of the Public Health Service Act (PHSA) as defined at section 1847A(6)(H) of the Act.

Source

42 CFR § 414.902

Scoping language

As used in this subpart, unless the context indicates otherwise