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Review
. 2024 Apr 18;25(5):88.
doi: 10.1208/s12249-024-02802-0.

A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book

Fuduan Chen #  1 , Hao Zhong #  1 , Ging Chan  1 , Defang Ouyang  2   3
Affiliations
Review

A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book

Fuduan Chen et al. AAPS PharmSciTech. .

Abstract

Although biopharmaceuticals constitute around 10% of the drug landscape, eight of the ten top-selling products were biopharmaceuticals in 2023. This study did a comprehensive analysis of the FDA's Purple Book database. Firstly, our research uncovered market trends and provided insights into biologics distributions. According to the investigation, although biotechnology has advanced and legislative shifts have made the approval process faster, there are still challenges to overcome, such as molecular instability and formulation design. Moreover, our research comprehensively analyzed biological formulations, pointing out significant strategies regarding administration routes, dosage forms, product packaging, and excipients. In conjunction with biologics, the widespread integration of innovative delivery strategies will be implemented to confront the evolving challenges in healthcare and meet an expanding array of treatment needs.

Keywords: biologics; biopharmaceutical landscape; dosage form; excipient; purple book.

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