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In this section: Economic Impact Analyses of FDA Regulations

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

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

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