Editor’s Choice Articles

Editor’s Choice articles are based on recommendations by the scientific editors of MDPI journals from around the world. Editors select a small number of articles recently published in the journal that they believe will be particularly interesting to readers, or important in the respective research area. The aim is to provide a snapshot of some of the most exciting work published in the various research areas of the journal.

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21 pages, 1641 KiB  
Review
The Coming of Age of Biosimilars: A Personal Perspective
by Sarfaraz K. Niazi
Biologics 2022, 2(2), 107-127; https://doi.org/10.3390/biologics2020009 - 20 Apr 2022
Cited by 17 | Viewed by 9525
Abstract
Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the [...] Read more.
Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready. Full article
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15 pages, 345 KiB  
Review
Therapeutic Role of Antimicrobial Peptides in Diabetes Mellitus
by Julia Depta, Paulina Małkowska, Monika Wysokińska, Karolina Todorska, Olga Sierawska, Rafał Hrynkiewicz, Dominika Bębnowska and Paulina Niedźwiedzka-Rystwej
Biologics 2022, 2(1), 92-106; https://doi.org/10.3390/biologics2010008 - 18 Mar 2022
Cited by 6 | Viewed by 4219
Abstract
Antimicrobial peptides (AMPs) have recently become widely publicized because they have the potential to function in alternative therapies as “natural” antibiotics, with their main advantage being a broad spectrum of activity. The potential for antimicrobial peptides to treat diabetes mellitus (DM) has been [...] Read more.
Antimicrobial peptides (AMPs) have recently become widely publicized because they have the potential to function in alternative therapies as “natural” antibiotics, with their main advantage being a broad spectrum of activity. The potential for antimicrobial peptides to treat diabetes mellitus (DM) has been reported. In diabetes mellitus type I (T1D), cathelicidin-related antimicrobial peptide (CRAMP), cathelicidin antimicrobial peptide (CAMP) and mouse-β- defensin 14 (mBD14) are positively affected. Decreased levels of LL-37 and human neutrophil peptide 1-3 (HNP1-3) have been reported in diabetes mellitus type II (T2D) relative to healthy patients. Moreover, AMPs from amphibians and social wasps have antidiabetic effects. In infections occurring in patients with tuberculosis-diabetes or diabetic foot, granulysin, HNP1, HNP2, HNP3, human beta-defensin 2 (HBD2), and cathelicidins are responsible for pathogen clearance. An interesting alternative is also the use of modified M13 bacteriophages containing encapsulated AMPs genes or phagemids. Full article
(This article belongs to the Special Issue Antimicrobial Peptides for Therapeutic Applications)
11 pages, 439 KiB  
Review
The Promising Role of Mushrooms as a Therapeutic Adjuvant of Conventional Cancer Therapies
by Ana Isabel Plácido, Fátima Roque and Manuel Morgado
Biologics 2022, 2(1), 58-68; https://doi.org/10.3390/biologics2010005 - 29 Jan 2022
Cited by 4 | Viewed by 4713
Abstract
Complementary and alternative medicine (CAM) has been fronted as an alternative due to its potential for holistic treatment. Many CAMs are plant-derived, including algae and mushrooms that have been used widely in many parts of the world, where they are regarded as biological [...] Read more.
Complementary and alternative medicine (CAM) has been fronted as an alternative due to its potential for holistic treatment. Many CAMs are plant-derived, including algae and mushrooms that have been used widely in many parts of the world, where they are regarded as biological response modifiers. The purpose of this article was to review the role of mushrooms as an adjuvant in conventional therapies, to reveal the therapeutic substances of mushrooms as an adjuvant in conventional therapies, to bring together the available scientific data on the medical effects of mushrooms in oncology, and verify its efficacy and safety. A literature search was conducted in September 2021 on the MEDLINE-PubMed and Cochrane databases to identify relevant randomized controlled trials or clinical trials studies addressing the use of whole mushroom formulations as complementary therapy during conventional cancer treatment.: The findings from the present study suggest that mushrooms may act as a potentiator of host defense mechanisms and decrease adverse events for patients with cancer undergoing conventional therapies. New protocols to conduct clinical trials are needed to elucidate the possible active mechanisms and clinical benefits of these fungi in various types of cancer. Full article
(This article belongs to the Section Natural Products)
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20 pages, 1621 KiB  
Review
Nucleic Acid Vaccines for COVID-19: A Paradigm Shift in the Vaccine Development Arena
by Vivek P. Chavda, Md Kamal Hossain, Jayesh Beladiya and Vasso Apostolopoulos
Biologics 2021, 1(3), 337-356; https://doi.org/10.3390/biologics1030020 - 23 Oct 2021
Cited by 50 | Viewed by 11543
Abstract
Coronavirus disease, COVID-19, has touched every country globally except five countries (North Korea, Turkmenistan, Tonga, Tuvalu and Nauru). Vaccination is the most effective method to protect against infectious diseases. The objective is to ensure that everyone has access to a COVID-19 vaccine. The [...] Read more.
Coronavirus disease, COVID-19, has touched every country globally except five countries (North Korea, Turkmenistan, Tonga, Tuvalu and Nauru). Vaccination is the most effective method to protect against infectious diseases. The objective is to ensure that everyone has access to a COVID-19 vaccine. The conventional vaccine development platforms are complex and time-consuming to obtain desired approved vaccine candidates through rigorous regulatory pathways. These safeguards guarantee that the optimized vaccine product is safe and efficacious for various demographic populations prior to it being approved for general use. Nucleic acid vaccines employ genetic material from a pathogen, such as a virus or bacteria, to induce an immune response against it. Based on the vaccination, the genetic material might be DNA or RNA; as such, it offers instructions for producing a specific pathogen protein that the immune system will perceive as foreign and mount an immune response. Nucleic acid vaccines for multiple antigens might be made in the same facility, lowering costs even more. Most traditional vaccine regimens do not allow for this. Herein, we demonstrate the recent understanding and advances in nucleic acid vaccines (DNA and mRNA based) against COVID-19, specifically those in human clinical trials. Full article
(This article belongs to the Special Issue Anti-SARS-CoV-2/COVID-19 Drugs and Vaccines)
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22 pages, 1485 KiB  
Review
Involvement of Probiotics and Postbiotics in the Immune System Modulation
by Neslihan Yeşilyurt, Birsen Yılmaz, Duygu Ağagündüz and Raffaele Capasso
Biologics 2021, 1(2), 89-110; https://doi.org/10.3390/biologics1020006 - 06 Jul 2021
Cited by 71 | Viewed by 16277
Abstract
Intestinal microbiota interacts with other systems, especially the immune system, which is responsible for protecting the body by recognizing “stranger” (pathogen associated molecular patterns-PAMPs) and “danger” (damage-associated molecular patterns-DAMPs) molecular motifs. In this manner, it plays an important role in the pathogenesis of [...] Read more.
Intestinal microbiota interacts with other systems, especially the immune system, which is responsible for protecting the body by recognizing “stranger” (pathogen associated molecular patterns-PAMPs) and “danger” (damage-associated molecular patterns-DAMPs) molecular motifs. In this manner, it plays an important role in the pathogenesis of various diseases and health. Despite the use of probiotics that modulate the intestinal microbiota in providing health benefits and in the treatment of diseases, there are some possible concerns about the possibility of developing adverse effects, especially in people with suppressed immune systems. Since probiotics provide health benefits with bioactive compounds, studies are carried out on the use of products containing non-living probiotic microorganisms (paraprobiotics) and/or their metabolites (postbiotics) instead of probiotic products. It is even reported that these microbial compounds have more immunomodulatory activities than living microorganisms via some possible mechanism and eliminates some disadvantages of probiotics. Considering the increasing use of functional foods in health and disease, further studies are needed with respect to the benefits and advantages of parabiotic and/or postbiotic use in the food and pharmaceutical industry as well as immune system modulation. Although probiotics have been extensive studied for a long time, it seems that postbiotics are promising tools for future research and applications according to the recent literature. This review aimed to evaluate the interaction of probiotics and postbiotics with the immune systems and also their advantages and disadvantages in the area of food-pharmaceutical industry and immune system modulation. Full article
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1 pages, 173 KiB  
Editorial
Biologics—An Open Access Journal for Biological Drugs
by Raffaele Capasso
Biologics 2021, 1(1), 1; https://doi.org/10.3390/biologics1010001 - 11 Mar 2021
Viewed by 2780
Abstract
Biological drugs have been attracting interest from the scientific community in recent years [...] Full article
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