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Pharmaceutics
Special Issues
Medical Applications of Biologic Drugs
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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: closed (20 April 2026) | Viewed by 20198

Special Issue Editors

Dr. Carmen Maximiliana Dobrea

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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
Dr. Adina Frum

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; phytochemical analyses; antioxidants; polyphenols; environmental sciences; dendrimers; drug delivery; nutrivigilance
Special Issues, Collections and Topics in MDPI journals
Dr. Anca Butuca

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
Dr. Claudiu Morgovan

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Guest Editor
Faculty of Medicine, Lucian Blaga University, 2A, Lucian Blaga Str., 550169 Sibiu, Romania
Interests: pharmacology; drug safety; antimicrobial resistance; drug efficacy
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Prof. Dr. Felicia-Gabriela Gligor

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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; drug delivery; analytical methods; biochemistry; laboratory tests; antioxidants; dendrimers; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Cristina Adriana Dehelean

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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

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

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 (4 papers)

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Research

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21 pages, 2220 KB  
Article
Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin)
by Khalid Kadhem Al-Kinani, Hussein Kadhum Alkufi and Salam Shanta Taher
Pharmaceutics 2026, 18(3), 383; https://doi.org/10.3390/pharmaceutics18030383 - 20 Mar 2026
Viewed by 601
Abstract
Background: Trastuzumab is a blockbuster monoclonal antibody that has revolutionized the treatment of HER2-positive breast and gastric cancers. With the increasing availability of biosimilar monoclonal antibodies in clinical practice, independent verification of biosimilarity using products sampled from a real-world supply chain is [...] Read more.
Background: Trastuzumab is a blockbuster monoclonal antibody that has revolutionized the treatment of HER2-positive breast and gastric cancers. With the increasing availability of biosimilar monoclonal antibodies in clinical practice, independent verification of biosimilarity using products sampled from a real-world supply chain is important to assure clinicians and the patients to use these products confidently. Objective: The aim of this study is to assess the biosimilarity of AryoTrust, a trastuzumab biosimilar, in comparison with the reference product Herceptin. AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings. Methods: AryoTrust and Herceptin were compared using an extensive set of orthogonal analytical techniques which included SDS-PAGE, ion-exchange chromatography, capillary isoelectric focusing, peptide mapping, N-glycan profiling, circular dichroism, differential scanning calorimetry, and surface plasmon resonance. In addition to these teste, functional comparability was also tested using an HER2-dependent cell-based proliferation inhibition bioassay. Results: The results showed that both products have highly comparable profiles in all assessed attributes. The analysis showed similar molecular integrity and purity, identical primary structure, comparable charge heterogeneity, similar isoelectric points (pI) of the main isoform, close glycosylation patterns (mainly, by core-fucosylated complex-type glycans), similar higher-order structural features, and thermal stability. The receptor binding studies exhibited comparable binding affinities with Fcγ receptors and FcRn. Finally, the cell-based bioassay revealed comparable dose–response curves with similar EC50 values and relative potency. Conclusions: The integrated analytical and functional data support the biosimilarity of AryoTrust to the reference product Herceptin, which has been marketed and used in Iraq. This study provides real-world scientific evidence supporting confidence in the quality and comparability of this trastuzumab biosimilar and reduces any doubt in the product and at the same time emphasizes the value of independent post-marketing biosimilarity assessments. Full article
(This article belongs to the Special Issue Medical Applications of Biologic Drugs)
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Review

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53 pages, 2103 KB  
Review
An Overview of Anticoagulant Drugs Pharmacology, Therapeutic Approaches, Limitations and Perspectives
by Claudiu Morgovan, Adina Frum, Laurentiu Stoicescu, Anca Butuca, Carmen Maximiliana Dobrea, Anca Maria Arseniu, Adriana Aurelia Chis, Maria Lucia Muresan, Felicia Gabriela Gligor, Ioana Rada Popa Ilie and Steliana Ghibu
Pharmaceutics 2026, 18(2), 163; https://doi.org/10.3390/pharmaceutics18020163 - 26 Jan 2026
Viewed by 3009
Abstract
Coagulation is a physiological process necessary to achieve homeostasis. Many pathologies lead to spontaneous activation of the coagulation pathways and increase the risk of venous thrombosis (e.g., atrial fibrillation, orthopaedic surgery, cancer). Therefore, a lot of patients need anticoagulant drugs as preventive or [...] Read more.
Coagulation is a physiological process necessary to achieve homeostasis. Many pathologies lead to spontaneous activation of the coagulation pathways and increase the risk of venous thrombosis (e.g., atrial fibrillation, orthopaedic surgery, cancer). Therefore, a lot of patients need anticoagulant drugs as preventive or curative treatment. In general, older molecules (unfractionated heparin, low-molecular-weight heparins, vitamin K antagonists) have good efficacy. Still, their adverse reactions, increased risk of bleeding, or difficult administration led to low adherence to treatment and had even limited their use. Recently, new molecules were authorised to improve patient adherence to treatment, mainly formulated for oral administration (e.g., dabigatran, rivaroxaban, apixaban, etc.). This therapeutic approach has a low risk of bleeding and does not require special monitoring by laboratory tests. Also, new anticoagulants for patients with heparin-induced thrombocytopenia (e.g., argatroban, lepirudin, bivalirudin, etc.) were obtained. Moreover, reversal agents for the new anticoagulant molecules used in overdoses or in situations where immediate cessation of the anticoagulant effect is required (e.g., emergency surgery) were studied, some of them being authorised on the pharmaceutical market. This narrative review aims to provide a pharmacological and therapeutic overview of anticoagulant drugs, underlining their implementation and limitations. Full article
(This article belongs to the Special Issue Medical Applications of Biologic Drugs)
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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 16 | Viewed by 12620
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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Other

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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
Cited by 1 | Viewed by 3007
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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