Medical Applications of Biologic Drugs

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biologics and Biosimilars".

Deadline for manuscript submissions: 20 April 2026 | Viewed by 9240

Special Issue Editors


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Guest Editor
Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 2A Lucian Blaga St., 550169 Sibiu, Romania
Interests: natural products; antioxidants; phytochemicals; nutrivigilance; toxicology; dendrimers; drug delivery
Special Issues, Collections and Topics in MDPI journals
Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 2A Lucian Blaga St., 550169 Sibiu, Romania
Interests: natural products; phytochemical analyses; antioxidants; polyphenols; environmental sciences; dendrimers; drug delivery; nutrivigilance
Special Issues, Collections and Topics in MDPI journals

E-Mail Website
Guest Editor
Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 2A Lucian Blaga St., 550169 Sibiu, Romania
Interests: natural products; drug delivery; dendrimers; analytical methods; antioxidants; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals

E-Mail Website
Guest Editor
Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 2A Lucian Blaga St., 550169 Sibiu, Romania
Interests: natural products; drug delivery; analytical methods; biochemistry; laboratory tests; antioxidants; dendrimers; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals

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Guest Editor
Faculty of Pharmacy, “Victor Babes” University of Medicine and Pharmacy, Eftimie Murgu Square No. 2, 300041 Timisoara, Romania
Interests: toxicological assessment; cancer and degenerative disease; experimental models; natural products; drug delivery; new formulations
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Since the 1980s, biologic drugs have revolutionized disease management by offering distinct benefits in optimizing therapeutic outcomes and improving the quality of life. These smart delivery systems can provide a targeted delivery of drugs, an enhanced efficacy, and a lower risk of side effects. In the era of personalized medicine, the use of biologic drugs represents an innovative treatment, and is more and more spread in different therapeutic areas, from cancer therapy to regenerative medicine. 
The purpose of this Special Issue is to collect papers that offer novel insights in the field of biologics such as chemical, pharmacological, and toxicological properties, technological processes, and therapeutical activity. Key areas include design, preparations and characterizations of biologics, drug delivery systems, drug delivery challenges, formulation, pharmacokinetics, biopharmaceuticals, drug release and action mechanisms, in vitro and in vivo studies regarding their effectiveness or toxicity, therapeutic and clinical evaluations, etc.

Authors are invited to send manuscripts including original research or literature reviews referring to biologic drugs used in different medical domains.

Dr. Carmen Maximiliana Dobrea
Dr. Adina Frum
Dr. Anca Butuca
Dr. Claudiu Morgovan
Prof. Dr. Felicia-Gabriela Gligor
Prof. Dr. Cristina Adriana Dehelean
Guest Editors

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Keywords

  • monoclonal antibodies
  • vaccines
  • hormones
  • biologic enzymes
  • immunosuppressants
  • immunomodulators
  • biologic drug development
  • mechanism of action
  • safety and efficacy
  • therapeutic outcomes
  • biosimilars
  • gene therapy

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Published Papers (2 papers)

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Review

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38 pages, 8552 KB  
Review
Enzyme-Based Anti-Inflammatory Therapeutics for Inflammatory Diseases
by Kannan Badri Narayanan
Pharmaceutics 2025, 17(5), 606; https://doi.org/10.3390/pharmaceutics17050606 - 2 May 2025
Cited by 5 | Viewed by 8816
Abstract
Inflammation is a multifaceted biological response of the immune system against various harmful stimuli, including pathogens (such as bacteria and viruses), cellular damage, toxins, and natural/synthetic irritants. This protective mechanism is essential for eliminating the cause of injury, removing damaged cells, and initiating [...] Read more.
Inflammation is a multifaceted biological response of the immune system against various harmful stimuli, including pathogens (such as bacteria and viruses), cellular damage, toxins, and natural/synthetic irritants. This protective mechanism is essential for eliminating the cause of injury, removing damaged cells, and initiating the repair process. While inflammation is a fundamental component of the body’s defense and healing process, its dysregulation can lead to pathological consequences, contributing to various acute and chronic diseases, such as autoimmune disorders, cancer, metabolic syndromes, cardiovascular diseases, neurodegenerative conditions, and other systemic complications. Generally, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, disease-modifying anti-rheumatic drugs (DMARDs), antihistamines, biologics, and colchicine are used as pharmacological agents in the management of inflammatory diseases. However, these conventional treatments often have limitations, including adverse side effects, long-term toxicity, and drug resistance. In contrast, enzyme-based therapeutics have emerged as a promising alternative due to their high specificity, catalytic efficiency, and ability to modulate inflammatory pathways with reduced side effects. These enzymes function by scavenging reactive oxygen species (ROS), inhibiting cytokine transcription, degrading circulating cytokines, and blocking cytokine release by targeting exocytosis-related receptors. Additionally, their role in tissue repair and regeneration further enhances their therapeutic potential. Most natural anti-inflammatory enzymes belong to the oxidoreductase class, including catalase and superoxide dismutase, as well as hydrolases such as trypsin, chymotrypsin, nattokinase, bromelain, papain, serratiopeptidase, collagenase, hyaluronidase, and lysozyme. Engineered enzymes, such as Tobacco Etch Virus (TEV) protease and botulinum neurotoxin type A (BoNT/A), have also demonstrated significant potential in targeted anti-inflammatory therapies. Recent advancements in enzyme engineering, nanotechnology-based enzyme delivery, and biopharmaceutical formulations have further expanded their applicability in treating inflammatory diseases. This review provides a comprehensive overview of both natural and engineered enzymes, along with their formulations, used as anti-inflammatory therapeutics. It highlights improvements in stability, efficacy, and specificity, as well as minimized immunogenicity, while discussing their mechanisms of action and clinical applications and potential future developments in enzyme-based biomedical therapeutics. Full article
(This article belongs to the Special Issue Medical Applications of Biologic Drugs)
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25 pages, 2338 KB  
Systematic Review
Advances in β-Galactosidase Research: A Systematic Review from Molecular Mechanisms to Enzyme Delivery Systems
by Márton Király, Ádám Tibor Barna, Nikolett Kállai-Szabó, Borbála Dalmadiné Kiss, István Antal and Krisztina Ludányi
Pharmaceutics 2025, 17(12), 1538; https://doi.org/10.3390/pharmaceutics17121538 - 29 Nov 2025
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Abstract
Background/Objectives: β-galactosidase (lactase) is a transformative enzyme used in many different fields. Its significance spans from biotechnology to food and pharmaceutical industries. β-galactosidase catalyzes the hydrolysis of lactose into glucose and galactose. In medicine, β-galactosidase has gained attention and has many applications, mainly [...] Read more.
Background/Objectives: β-galactosidase (lactase) is a transformative enzyme used in many different fields. Its significance spans from biotechnology to food and pharmaceutical industries. β-galactosidase catalyzes the hydrolysis of lactose into glucose and galactose. In medicine, β-galactosidase has gained attention and has many applications, mainly in enzyme replacement therapy. β-galactosidase is the main active ingredient of medications for lactose intolerance. Industrially β-galactosidase is typically produced by the Aspergillus oryzae filamentous fungus. Therapeutic interventions involving β-galactosidase aim to mitigate symptoms and improve the patients’ quality of life. In the food industry, it plays a crucial role in the production of lactose-free products, improving accessibility to dairy products. However, despite its versatility and wide use, challenges connected to β-galactosidase still exist, such as the need for cost-effective and more efficient methods for administering the enzyme. Additionally, there are several ongoing studies that seek to enhance stability and optimize the performance of β-galactosidase in various applications. The aim of this manuscript is to summarize current knowledge about β-galactosidase as an active ingredient and to present some preparations that are commercially available or mentioned in the literature. Methods: A systematic search was conducted in PubMed, Scopus, Embase and Web of Science to identify relevant articles on formulations related to β-galactosidase, focusing on original research articles published between 1895 and 2025 that exclusively examine the use of oral drug delivery. Results: After a rigorous search across multiple databases, 45 relevant studies out of 1633 initial results were selected for analysis. Conclusions: β-galactosidase remains a highly versatile enzyme with broad industrial and medical relevance. While current formulations offer significant benefits, further innovation is needed to improve delivery efficiency, stability, and cost-effectiveness. The findings of this review contribute to a deeper understanding of β-galactosidase as an active ingredient and outline opportunities for advancing its application in oral drug delivery systems. Full article
(This article belongs to the Special Issue Medical Applications of Biologic Drugs)
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