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

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 substitute...

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Main Authors: Mohamed Halawa, Ramez M. Rashad ElSayed, Tope Aderibigbe, Precious M. Newman, Briana E. Reid, Valerie J. Carabetta
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/17/5/581
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author Mohamed Halawa
Ramez M. Rashad ElSayed
Tope Aderibigbe
Precious M. Newman
Briana E. Reid
Valerie J. Carabetta
author_facet Mohamed Halawa
Ramez M. Rashad ElSayed
Tope Aderibigbe
Precious M. Newman
Briana E. Reid
Valerie J. Carabetta
author_sort Mohamed Halawa
collection DOAJ
description 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.
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spelling doaj-art-ea3b03ddbf694d6dba73960f88eb5cee2025-08-20T03:14:32ZengMDPI AGPharmaceutics1999-49232025-04-0117558110.3390/pharmaceutics17050581Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral InfectionsMohamed Halawa0Ramez M. Rashad ElSayed1Tope Aderibigbe2Precious M. Newman3Briana E. Reid4Valerie J. Carabetta5Department of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USACancer Nanotechnology Research Laboratory (CNRL), Faculty of Pharmacy, Alexandria University, Alexandria P.O. Box 21521, EgyptDepartment of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USADepartment of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USADepartment of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USADepartment of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USABiosimilars 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.https://www.mdpi.com/1999-4923/17/5/581antibacterial biosimilarsantifungal biosimilarsantimicrobial peptidesantiviral biosimilarsinfection managementmonoclonal antibodies
spellingShingle Mohamed Halawa
Ramez M. Rashad ElSayed
Tope Aderibigbe
Precious M. Newman
Briana E. Reid
Valerie J. Carabetta
Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
Pharmaceutics
antibacterial biosimilars
antifungal biosimilars
antimicrobial peptides
antiviral biosimilars
infection management
monoclonal antibodies
title Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
title_full Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
title_fullStr Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
title_full_unstemmed Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
title_short Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections
title_sort biosimilars targeting pathogens a comprehensive review of their role in bacterial fungal parasitic and viral infections
topic antibacterial biosimilars
antifungal biosimilars
antimicrobial peptides
antiviral biosimilars
infection management
monoclonal antibodies
url https://www.mdpi.com/1999-4923/17/5/581
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