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Review
. 2024 Jul 10;17(7):925.
doi: 10.3390/ph17070925.

Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments

Tomas Gabriel Bas  1 , Vannessa Duarte  1
Affiliations
Review

Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments

Tomas Gabriel Bas et al. Pharmaceuticals (Basel). .

Abstract

This research is based on three fundamental aspects of successful biosimilar development in the challenging biopharmaceutical market. First, biosimilar regulations in eight selected countries: Japan, South Korea, the United States, Canada, Brazil, Argentina, Australia, and South Africa, represent the four continents. The regulatory aspects of the countries studied are analyzed, highlighting the challenges facing biosimilars, including their complex approval processes and the need for standardized regulatory guidelines. There is an inconsistency depending on whether the biosimilar is used in a developed or developing country. In the countries observed, biosimilars are considered excellent alternatives to patent-protected biological products for the treatment of chronic diseases. In the second aspect addressed, various analytical AI modeling methods (such as machine learning tools, reinforcement learning, supervised, unsupervised, and deep learning tools) were analyzed to observe patterns that lead to the prevalence of biosimilars used in cancer to model the behaviors of the most prominent active compounds with spectroscopy. Finally, an analysis of the use of active compounds of biosimilars used in cancer and approved by the FDA and EMA was proposed.

Keywords: EMA; FDA; artificial intelligence; biosimilars; cancer; continents; oncology; regulations.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Methodology used in the study [50,51,52].
Figure 2
Figure 2
Summary of regulations by country and continent.
Figure 3
Figure 3
Active components approved by the FDA for use of cancer treatment from “bevacizumab”.
Figure 4
Figure 4
Biosimilars approved in Canada, the United States, Brazil, and Europe to be applied in cancer treatments.
Figure 5
Figure 5
Total biosimilars approved for cancer treatment based on investment.
See this image and copyright information in PMC

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This research received no external funding.

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