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Journals BioDrugs : Clinical Immunother...

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy

https://read.qxmd.com/read/38890199/demonstration-of-physicochemical-and-functional-similarity-of-the-biosimilar-bat1806-biib800-to-reference-tocilizumab
#1
JOURNAL ARTICLE
Yujie Liu, Jianhua Xie, Zhuxiang Li, Xiong Mei, Di Cao, Shengfeng Li, Linda Engle, Suli Liu, Hans C Ebbers, Cuihua Liu
BACKGROUND AND OBJECTIVE: Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (tocilizumab-bavi) has been developed as a biosimilar to the reference product tocilizumab (TCZ). The objective of this study was to demonstrate physicochemical and functional similarity between BAT1806/BIIB800 and TCZ in a comprehensive comparability exercise. METHODS: A comprehensive panel of over 20 methods was used to generate datasets comparing critical and non-critical product quality attributes for 10 BAT1806/BIIB800 lots and 44 TCZ lots (16 sourced from China, 16 from the EU, and 12 from the US)...
June 18, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38879730/barriers-and-enablers-affecting-the-uptake-of-biosimilar-medicines-viewed-through-the-lens-of-actor-network-theory-a-systematic-review
#2
JOURNAL ARTICLE
Chad Rieger, Judith A Dean, Lisa Hall, Paola Vasquez, Gregory Merlo
BACKGROUND AND OBJECTIVE: Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic review is to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories...
June 15, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38874875/postmarketing-reports-of-incomplete-dosing-related-complications-with-self-injected-pcsk9-inhibitors-a-descriptive-study-and-disproportionality-analysis
#3
JOURNAL ARTICLE
Richard H Woods
BACKGROUND: Evolocumab and alirocumab are self-injected proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors indicated for low-density lipoprotein cholesterol reduction. Complications in the use or functionality of self-injection devices may precipitate incomplete dosing. OBJECTIVE: This study sought to characterize postmarketing dosing failure reports involving self-injected PCSK9 inhibitors. METHODS: US Food and Drug Administration Adverse Event Reporting System (FAERS) [2016-second quarter of 2023] data were utilized for a disproportionality analysis...
June 14, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38861154/charting-the-etanercept-journey-tracing-cost-dynamics-in-poland-s-off-patent-market-from-reference-drug-rivalry-to-biosimilar-monopoly
#4
JOURNAL ARTICLE
Marcin Stajszczyk, Krzysztof Batko, Zbigniew Michał Żuber, Brygida Kwiatkowska, Magdalena Krajewska-Włodarczyk, Bogdan Batko
OBJECTIVES: To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market. METHODS: We conducted a comprehensive, retrospective analysis of ETN market competition, specifically changes in tender price based on shifts in market monopoly, including the effects on cost evolution, in the off-patent market in Poland. We included a total of 473 tenders for ETN purchase in dedicated biologic drug reimbursement programs, covering both pre-filled syringes and automatic injectors...
June 11, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38767823/antibody-drug-conjugates-as-novel-therapeutic-agents-for-non-small-cell-lung-carcinoma-with-or-without-alterations-in-oncogenic-drivers
#5
REVIEW
Laura Bender Somme, Christos Chouaid, Fabien Moinard-Butot, Jean-Baptiste Barbe-Richaud, Laurent Greillier, Roland Schott
Antibody-drug conjugates (ADCs) are an emerging class of therapeutics for lung cancer, and several are currently in development for this malignancy. The structure of these molecules is based on an antibody that targets a protein on the lung cancer cell surface and a cytotoxic payload attached by a linker. Many protein targets, including TROP2, c-MET, CEACAM5, HER2, and HER3 have been identified. In metastatic non-small cell lung carcinoma (NSCLC) without alterations in oncogenic drivers, platinum-based chemotherapy and immune checkpoint inhibitors (ICIs) targeting the programmed death-1/programmed death-ligand 1 (PD1/PDL1) interaction are the standard first-line treatments...
May 20, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38700835/emerging-innate-immune-cells-in-cancer-immunotherapy-promises-and-challenges
#6
REVIEW
Jennifer Wu
Immune checkpoint inhibitor (ICI)-based therapy has made an unprecedented impact on survival benefit for a subset of cancer patients; however, only a subset of cancer patients is benefiting from ICI therapy if all cancer types are considered. With the advanced understanding of interactions of immune effector cell types and tumors, cell-based therapies are emerging as alternatives to patients who could not benefit from ICI therapy. Pioneering work of chimeric antigen receptor T (CAR-T) therapy for hematological malignancies has brought encouragement to a broad range of development for cellular-based cancer immunotherapy, both innate immune cell-based therapies and T-cell-based therapies...
May 3, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38643301/impact-of-early-access-reform-on-oncology-innovation-in-france-approvals-patients-and-costs
#7
JOURNAL ARTICLE
Tess Martin, Catherine Rioufol, Bertrand Favier, Nicolas Martelli, Isabelle Madelaine, Christos Chouaid, Isabelle Borget
BACKGROUND: An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs. OBJECTIVE: This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients. METHODS: The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022...
April 20, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38605260/crispr-cas-system-a-new-dawn-to-combat-antibiotic-resistance
#8
REVIEW
Muhammad Shahzad Rafiq, Muhammad AbuBakar Shabbir, Ahmed Raza, Shoaib Irshad, Andleeb Asghar, Muhammad Kashif Maan, Mushtaq Ahmed Gondal, Haihong Hao
Antimicrobial resistance (AMR) can potentially harm global public health. Horizontal gene transfer (HGT), which speeds up the emergence of AMR and increases the burden of drug resistance in mobile genetic elements (MGEs), is the primary method by which AMR genes are transferred across bacterial pathogens. New approaches are urgently needed to halt the spread of bacterial diseases and antibiotic resistance. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), an RNA-guided adaptive immune system, protects prokaryotes from foreign DNA like plasmids and phages...
April 11, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38584236/next-generation-anti-tnf%C3%AE-agents-the-example-of-ozoralizumab
#9
REVIEW
Kouhei Tsumoto, Tsutomu Takeuchi
Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the management of patients with immune-mediated inflammatory diseases, including rheumatoid arthritis, thus benefiting many patients. Nevertheless, the inability of some patients to achieve low disease activity or clinical remission remains a major concern. To address such concerns, next-generation anti-TNFα agents that differ from the immunoglobulin G-format anti-TNFα agents that have been used to date are being developed using antibody-engineering technology...
April 8, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38520608/research-advances-in-stem-cell-therapy-for-erectile-dysfunction
#10
REVIEW
Wei Wang, Ying Liu, Zuo-Bin Zhu, Kun Pang, Jing-Kai Wang, Jun Gu, Zhen-Bei Li, Jian Wang, Zhen-Duo Shi, Cong-Hui Han
Erectile dysfunction (ED) is a common clinical condition that mainly affects men aged over 40 years. Various causes contribute to the progression of ED, including pelvic nerve injury, diabetes, metabolic syndrome, age, Peyronie's disease, smoking, and psychological disorders. Current treatments for ED are limited to symptom relief and do not address the root cause. Stem cells, with their powerful ability to proliferate and differentiate, are a promising approach for the treatment of male ED and are gradually gaining widespread attention...
May 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38489062/safety-of-biological-therapies-for-severe-asthma-an-analysis-of-suspected-adverse-reactions-reported-in-the-who-pharmacovigilance-database
#11
JOURNAL ARTICLE
Paola Maria Cutroneo, Elena Arzenton, Fabiana Furci, Fabio Scapini, Maria Bulzomì, Nicoletta Luxi, Marco Caminati, Gianenrico Senna, Ugo Moretti, Gianluca Trifirò
BACKGROUND: The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to August 2022, five biologics have been approved for the type 2 asthma phenotype: anti-IgE (omalizumab), anti-IL5 (mepolizumab, reslizumab, benralizumab), and anti-IL4 (dupilumab) monoclonal antibodies. These drugs are usually well tolerated, although long-term safety information is limited, and some adverse events have not yet been fully characterized. Spontaneous reporting systems represent the cornerstone for the detection of potential signals and evaluation of the real-world safety of all marketed drugs...
May 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38520607/additional-data-in-expanded-patient-populations-and-new-indications-support-the-practice-of-biosimilar-to-biosimilar-switching
#12
JOURNAL ARTICLE
Hillel P Cohen, Wolfram Bodenmueller
As of 31 December, 2023, 31 observational studies have been published, including a total of 6081 patients who underwent a switch from one biosimilar to another biosimilar of the same reference biologic. Most studies evaluated infliximab, while a smaller number evaluated adalimumab, rituximab or etanercept. Indications studied now include sarcoidosis, as well as the indications previously reported of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis and inflammatory bowel disease (Crohn's disease and ulcerative colitis)...
March 23, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38489061/targeted-gene-insertion-the-cutting-edge-of-crispr-drug-development-with-hemophilia-as-a-highlight
#13
REVIEW
Zhenjie Zhang, Siqi Zhang, Hoi Ting Wong, Dali Li, Bo Feng
The remarkable advance in gene editing technology presents unparalleled opportunities for transforming medicine and finding cures for hereditary diseases. Human trials of clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein-9 nuclease (Cas9)-based therapeutics have demonstrated promising results in disrupting or deleting target sequences to treat specific diseases. However, the potential of targeted gene insertion approaches, which offer distinct advantages over disruption/deletion methods, remains largely unexplored in human trials due to intricate technical obstacles and safety concerns...
March 15, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38472644/use-of-biosimilars-a-systematic-review-of-published-position-statements-and-recommendations-from-health-organisations-and-societies
#14
Noraisyah Mohd Sani, Zoriah Aziz, Adeeba Kamarulzaman
BACKGROUND: Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence...
March 12, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38402495/cardiovascular-adverse-drug-reactions-of-anti-calcitonin-gene-related-peptide-monoclonal-antibodies-for-migraine-prevention-an-analysis-from-the-european-spontaneous-adverse-event-reporting-system
#15
JOURNAL ARTICLE
Emanuela Elisa Sorbara, Maria Antonietta Barbieri, Giulia Russo, Giuseppe Cicala, Edoardo Spina
INTRODUCTION: Anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAbs) have recently been approved for the prevention of migraine, and their safety profile is not fully characterized. OBJECTIVE: The aim of this study was to evaluate the adverse drug reactions (ADRs) of anti-CGRP-mAbs through the analysis of individual case safety reports (ICSRs) collected in the EudraVigilance (EV) database, with a specific focus on cardiovascular (CV) ADRs. METHODS: Data on ICSRs recorded between July 2018 and December 2022 in the EV database, involving one of the anti-CGRP-mAbs for migraine prevention-erenumab (ERE), galcanezumab (GMB), fremanezumab (FMB), and eptinezumab (EPT)-were included in the analysis...
March 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38236523/could-a-long-acting-prodrug-of-sn-38-be-efficacious-in-sacituzumab-govitecan-resistant-tumors
#16
JOURNAL ARTICLE
Daniel V Santi, Gary W Ashley, Luc Cabel, Francois-Clement Bidard
We previously proposed that sacituzumab govitecan (SG, Trodelvy®) likely acts as a simple prodrug of systemic SN-38 as well as an antibody drug conjugate (ADC). In the present commentary, we assess whether a long-acting SN-38 prodrug, such as PLX038, might be efficacious in SG-resistant patients. We first describe possible mechanisms of action of SG, with new insights on pharmacokinetics and TROP2 receptor occupancy. We argue that SG is not an optimal conventional ADC and that the amount of systemic SN-38 spontaneously hydrolyzed from the ADC is so high it must have activity...
March 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38194016/safety-tolerability-and-preliminary-efficacy-of-serplulimab-a-novel-anti-pd-1-antibody-in-patients-with-metastatic-or-recurrent-solid-tumors-a-phase-i-study
#17
JOURNAL ARTICLE
Ching-Liang Ho, Tsu-Yi Chao, Chia-Lun Chang, Hsuan-Yu Lin
BACKGROUND: Serplulimab is a novel, recombinant, humanized, monoclonal, anti-programmed death 1 antibody with a similar or better affinity and pre-clinical antitumor activity than pembrolizumab and nivolumab. OBJECTIVE: This phase I, open-label, dose-escalation study evaluated serplulimab in patients with advanced solid tumors. The second interim analysis of the dose-finding phase is reported here. METHODS: Adult patients with histologically confirmed metastatic/recurrent solid tumors who had progressed on, or were intolerant to/clinically unsuitable for standard treatment, were enrolled...
March 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38407791/can-endangered-biosimilar-markets-be-rescued-the-need-to-bridge-competing-interests-for-long-term-gain
#18
LETTER
Teresa Barcina Lacosta, Arnold G Vulto, Florian Turk, Isabelle Huys, Steven Simoens
Market signals such as: (1) the limited number of biosimilars in the development pipeline, (2) the focus of biosimilar development on high-profit therapeutic areas only, and (3) the increase in the number of biosimilar discontinuations and withdrawals, are indicative of sustainability threats facing biosimilar markets in Europe. Two prominent factors that undermine sustainability are: competing interests between the various stakeholders and a preferential focus on short-term gains, disregarding future sustainability threats, hence the need for effective policies that create sustainable competition in biologic markets...
February 26, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38402494/consensus-based-overarching-principles-and-recommendations-on-the-use-of-biosimilars-in-the-treatment-of-inflammatory-arthritis-in-the-gulf-region
#19
JOURNAL ARTICLE
Khalid A Alnaqbi, Nasra Al Adhoubi, Sara Aldallal, Samar Al Emadi, Adeeba Al-Herz, Amin M El Shamy, Suad Hannawi, Mohammed A Omair, Sahar A Saad, Tore K Kvien
BACKGROUND: Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication. OBJECTIVE: The objective of this initiative was to develop an evidence-based consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region...
February 25, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38345754/nano-bio-interactions-exploring-the-biological-behavior-and-the-fate-of-lipid-based-gene-delivery-systems
#20
REVIEW
Seigo Kimura, Hideyoshi Harashima
Gene therapy for many diseases is rapidly becoming a reality, as demonstrated by the recent approval of various nucleic acid-based therapeutics. Non-viral systems such as lipid-based carriers, lipid nanoparticles (LNPs), for delivering different payloads including small interfering RNA, plasmid DNA, and messenger RNA have been particularly extensively explored and developed for clinical uses. One of the most important issues in LNP development is delivery to extrahepatic tissues. To achieve this, various lipids and lipid-like materials are being examined and screened...
February 12, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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