BioDrugs journal

01/07/2024

This noninferiority study examines outcomes of rituximab-abbs versus reference rituximab in patients with diffuse large B-cell lymphoma in an integrated health care system in California, USA.

Background Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for diffuse large B-cell lymphoma (DLBCL). Rituximab comprises most of the treatment cost for this regimen; therefore, biosimilars, such as rituximab-abbs are crucial to....

25/06/2024

The article by Amy Lightner and colleagues reviews the current literature regarding cellular therapeutics for IBD, their limitations, and potential future technological advances to overcome these limitations.

Inflammatory bowel disease remains a difficult disease to effectively treat, especially fistulizing Crohn’s disease. Perianal fistulas in the setting of Crohn’s disease remain an area of unmet need with significant morbidity in this patient population. Up to one third of Crohn’s patients will ...

25/06/2024

This review provides an overview of the general mechanisms of action and design features of antisense oligonucleotides (A*Os), as well specific information on each of the FDA-approved A*O drugs.

Antisense oligonucleotides (A*Os) are single stranded nucleic acids that target RNA. The US Food and Drug Administration has approved A*Os for several diseases. A*Os utilize three principal modes of action (MOA). The first MOA is initiated by base-pairing between the A*O and its target mRNA, followe...

20/06/2024

This study describes the comparative analytical assessment of the biosimilar BAT1806/BIIB800 to reference tocilizumab.

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 physicochemi...

20/06/2024

This systematic review summarises the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional, patient, or systemic categories.

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 identifie...

17/06/2024

Utilizing spontaneous adverse event data, this study found that failure to administer an intended dose has been frequently reported to the US Food and Drug Administration in association with PCSK9 inhibitors in the postmarketing setting.

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 s...

16/06/2024

This analysis in Poland of etanercept cost dynamics illustrates the effects of market re-monopolization by a biosimilar drug.

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, incl...

27/05/2024

This review summarizes the knowledge about the efficacy and tolerance profiles of antibody-drug conjugates targeting TROP2, HER2, HER3, CEACAM5 and c-MET in metastatic NSCLC with and without alterations in oncogenic drivers.

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 l...

05/05/2024

Jennifer Wu discusses the potential of innate immune cells such as natural killer (NK) cells, γδ T cells, and macrophages for cancer immunotherapy.

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...

21/04/2024

The early access reform in France has enabled rapid access to innovation, particularly for oncology drugs. The reform also led to a significant increase in the annual number of patients treated and the reimbursement costs.

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....

15/04/2024

This review article investigates the CRISPR-Cas system’s potential as a tool to combat antibacterial resistance

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 path...

25/03/2024

This article in BioDrugs journal reviews recent advances in basic research and clinical applications of stem cells for the treatment of erectile dysfunction of different etiologies.

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 fo...

17/03/2024

This paper reviews the recent advances in preclinical studies demonstrating in vivo targeted gene insertion for therapeutic benefits, targeting somatic solid tissues through systemic delivery, and highlights hemophilia as a prominent disease model.

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...

17/03/2024

Gianluca Trifirò and colleagues provide an overview of safety data of biologics for severe asthma using VigiBase, the WHO global pharmacovigilance database. They identified several potential safety signals.

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 (dupi...

14/03/2024

This systematic review describes and assesses the recommendations of published position statements regarding several aspects of biosimilars across specialties and determines whether these positions have changed with the emergence of new evidence.

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 t...

14/03/2024

Teresa Barcina Lacosta and colleagues aim to raise awareness of the vulnerabilities of biosimilar markets and of difficulties in reaching an agreement on policy solutions with a long-term vision. They propose applying the learnings of collective action theory to healthcare to motivate stakeholders to prioritize long-term solutions over short-term gains.

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...

25/02/2024

Edoardo Spina and colleagues report on cardiovascular adverse drug reactions of anti-calcitonin gene-related peptide monoclonal antibodies from the EudraVigilance database.

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-mAb...

25/02/2024

A multidisciplinary task force from across the Gulf region developed recommendations and overarching principles to address
questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region.

https://link.springer.com/article/10.1007/s40259-023-00642-1

12/02/2024

This review provides an overview of lipid nanoparticle (LNP)-based nucleic acid delivery focusing on LNP components and their structures, as well as discussing biological factors, such as biomolecular corona and cellular responses related to the delivery efficiency. https://link.springer.com/article/10.1007/s40259-024-00647-4

29/01/2024

Karen Manoutcharian & Goar Gevorkian summarize data on recombinant antibody fragments evaluated as immunotherapeutics in pre-clinical models of Parkinson’s disease and discuss their potential for developing therapeutic and preventive protocols for patients with PD.

Parkinson’s disease (PD) is the second most common age-related neurodegenerative disorder. Multiple genetic and environmental factors leading to progressive loss of dopaminergic neurons in the substantia nigra pars compacta (SN) and consequent depletion of dopamine were described. Current clinical...

21/01/2024

The January issue of BioDrugs is now online

Volume 38, issue 1 articles listing for BioDrugs

15/01/2024

This survey study assesses the perception of biosimilars and prescribing practices among oncologists in South Korea.

https://link.springer.com/article/10.1007/s40259-023-00640-3

18/12/2023

A huge thank you to all our authors, peer reviewers and Editorial Board members who contributed their time and effort to guarantee the quality of the content published in BioDrugs journal in 2023.
Best wishes for the festive season
Kathy Fraser, Editor

10/12/2023

This study concluded that the availability of biosimilars was associated with a decrease in adalimumab expenditure without compromising the consumption of adalimumab.

Objective The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and upper-middle-income countries. Methods This study analyzed Multinational Integrated Data Analysis System (MIDAS)-IQVIA data from the fourth quarter (Q4) of 2018 to the....

27/11/2023

This review by Jamie Spangler and colleagues highlights the immense potential to leverage the immunoregulatory properties of IL-2 for targeted treatment of autoimmune and inflammatory diseases.

The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. Its immunosuppressive effects have been harnessed therapeutically via administration of low cytokine doses. Low-dose IL-2 has shown promise in the treatment of various autoimmune...

23/11/2023

The role of the interleukin (IL)-6 pathway in the treatment of rheumatoid arthritis has the potential to progress with different inhibitions of this pathway such as IL-6 cytokine blockade and trans-signaling blockade, in addition to IL-6 receptor blockers.

The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of treatment-resistant patients. In this context, interleukin (IL)-6 inhibition has filled an important gap in rheumatoid arthritis treatment with its effectiveness and safety in bo...

14/11/2023

Jeffrey Cummings and colleagues provide an excellent review of approved and upcoming anti-amyloid monoclonal antibodies for Alzheimer's disease.

Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiation of treatment in early Alzheimer's disease patients who have proven β-amyloid pathology (Aβ). One of these, lecanemab, has subsequently received full approval and other mono...

06/11/2023

Patryk Konieczny and colleagues provide an analysis of dystrophin and utrophin amino acid sequences and structures, highlighting the importance of various dystrophin and utrophin domains in Duchenne muscular dystrophy treatment, and providing insights into designing novel therapeutic compounds with improved efficacy and decreased immunoreactivity.

Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medical management focuses mostly on symptomatic treatment, decades of research have resulted in first therapeutics able to restore the affected reading frame of dystrophin transcrip...

02/11/2023

This manuscript by Christopher Layton and colleagues provides an overview of strategies employing AAV-mediated gene delivery to treat age-related macular degeneration and diabetic retinopathy.

Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are vascular diseases with high prevalence, ranking among the leading causes of blindness and vision loss worldwide. Despite being effective, current treatments for AMD and DR are burdensome for patients and clinicians, resulting i...