Naming of Biological Products

Document Type

Article

Publication Title

U.S. Pharmacist

Abstract

Biological products are rapidly expanding in the United States, and they are currently the fastest-growing class of therapeutic products. Biological products are being developed for rare, difficult-to-treat disease states and disease states with no treatment options, as well as creating new options for treatable conditions. The FDA has identified potential safety concerns for patients using biological products. These concerns include inappropriate or unintended biological-product substitution, along with pitfalls in pharmacovigilance monitoring for biological products. Recent FDA guidance discusses concerns, proposes solutions, and describes nomenclature for naming biological products.

First Page

14

Last Page

17

Publication Date

6-1-2020

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