AI Article Synopsis
- Biopharmaceuticals make up about 10% of the drug market, yet they dominated sales in 2023, with eight of the top ten products being biopharmaceuticals.
- The study analyzed FDA's Purple Book to understand market trends, biologics distribution, and highlighted ongoing challenges such as molecular instability and formulation design despite advancements in biotechnology and faster approval processes.
- It also examined biological formulations and proposed strategies for administration routes, dosage forms, packaging, and excipients, emphasizing the need for innovative delivery methods to address evolving healthcare challenges.
Article 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.
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| http://dx.doi.org/10.1208/s12249-024-02802-0 | DOI Listing |
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