This proposed rule would designate the official names and the proper names of six biological products that fall under one of the following categories: (1) A reference product for an approved or publicly disclosed section 351(k) application (i.e., filgrastim (BLA 103353), pegfilgrastim (BLA 125031), infliximab (BLA 103772), and epoetin alfa (BLA 103234)); (2) a related biological product to one of these reference products (i.e., tbo-filgrastim (BLA 125294)); or (3) a biosimilar product (i.e., filgrastim-sndz (BLA 125553)).

Regulatory Impact Analysis

Designation of Official Names and Proper Names for Certain Biological Products (Proposed Rule)

Federal Register: 80 FR 2516552224, Friday, August 28, 2015

Docket: : FDA-2015-N-0101