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靶向病原体的生物类似药:对其在细菌、真菌、寄生虫和病毒感染中作用的全面综述

Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections.

作者信息

Halawa Mohamed, ElSayed Ramez M Rashad, Aderibigbe Tope, Newman Precious M, Reid Briana E, Carabetta Valerie J

机构信息

Department of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USA.

Cancer Nanotechnology Research Laboratory (CNRL), Faculty of Pharmacy, Alexandria University, Alexandria P.O. Box 21521, Egypt.

出版信息

Pharmaceutics. 2025 Apr 28;17(5):581. doi: 10.3390/pharmaceutics17050581.

Abstract

Biosimilars represent medicinal products that exhibit a high degree of similarity to an already sanctioned reference biologic agent, with negligible clinically significant disparities concerning safety, purity, or potency. These therapeutic modalities are formulated as economically viable substitutes for established biologics, thereby facilitating increased accessibility to sophisticated treatments for a range of medical conditions, including infectious diseases caused by bacterial, fungal, and viral pathogens. The current landscape of biosimilars includes therapeutic proteins, such as monoclonal antibodies, antimicrobial peptides, antiviral peptides, and antifungal peptides. Here, we discuss the obstacles inherent in the development of biosimilars, including the rapid mutation rates of pathogens. Furthermore, we discuss innovative technologies within the domain, including antibody engineering, synthetic biology, and cell-free protein synthesis, which exhibit potential for improving the potency and production efficiency of biosimilars. We end with a prospective outlook to highlight the importance and capacity of biosimilars to tackle emerging infectious diseases, highlighting the imperative need for ongoing research and financial commitment.

摘要

生物类似药是指与已获批的参照生物制剂高度相似的药品,在安全性、纯度或效力方面存在可忽略不计的临床显著差异。这些治疗方式被制成既定生物制剂的经济可行替代品,从而有助于提高一系列医疗状况(包括由细菌、真菌和病毒病原体引起的传染病)获得先进治疗的可及性。生物类似药的当前格局包括治疗性蛋白质,如单克隆抗体、抗菌肽、抗病毒肽和抗真菌肽。在此,我们讨论生物类似药开发中固有的障碍,包括病原体的快速突变率。此外,我们还讨论该领域的创新技术,包括抗体工程、合成生物学和无细胞蛋白质合成,这些技术在提高生物类似药的效力和生产效率方面具有潜力。我们以展望未来作结,强调生物类似药在应对新出现的传染病方面的重要性和能力,突出持续研究和资金投入的迫切需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb8f/12115129/fc24733951e0/pharmaceutics-17-00581-g001.jpg

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