Administration of CD4 + CD25 high CD127 − FoxP3 + Regulatory T Cells for Relapsing-Remitting Multiple Sclerosis: A Phase 1 Study
ConclusionsNo serious adverse events were reported in the 14 patients with MS treated with Treg cells in this study. The results suggest that IT administration is more promising than IV administration. Because of the low number of patients recruited, the statistical results may be underpowered and further studies are necessary to reach conclusions on efficacy and safety.Trial registrationEudraCT: 2014-004320-22; registered 18 November 2014. (Source: BioDrugs)
Source: BioDrugs - January 5, 2021 Category: Drugs & Pharmacology Source Type: research

Biosimilar Perceptions Among Healthcare Professionals and Commercial Medical Benefit Policy Analysis in the United States
ConclusionsFindings from this study outline the greatest perceived barriers to adoption of biosimilars from a variety of different stakeholders. Rebates from reference product manufacturers to payers was the main deterrent for biosimilar use. (Source: BioDrugs)
Source: BioDrugs - January 5, 2021 Category: Drugs & Pharmacology Source Type: research

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets
ConclusionThis budget impact analysis emphasised that increased use of intravenous rituximab and trastuzumab biosimilars may result in cost savings from the payer ’s perspective across the EU-5 countries. (Source: BioDrugs)
Source: BioDrugs - December 24, 2020 Category: Drugs & Pharmacology Source Type: research

Effect of Treatment with the PD-1/PD-L1 Inhibitors on Key Health Outcomes of Cancer Patients
ConclusionsAnti-PD ‐1/PD‐L1 therapy is expected to provide marked survival benefits for patients with cancer. This study demonstrated the potentially beneficial health impacts of utilizing the anti-PD‐1/PD‐L1 class at the population level. The findings could inform health policy decision makers about cancer ca re and ultimately enhance population health through rapid access to innovative cancer drugs. (Source: BioDrugs)
Source: BioDrugs - December 17, 2020 Category: Drugs & Pharmacology Source Type: research

A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study
ConclusionsThis study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters. (Source: BioDrugs)
Source: BioDrugs - December 11, 2020 Category: Drugs & Pharmacology Source Type: research

Emerging Targeted Therapies for Neuromyelitis Optica Spectrum Disorders
AbstractNeuromyelitis optica spectrum disorder (NMOSD) is an autoimmune, inflammatory disorder of the central nervous system that typically presents with recurrent episodes of optic neuritis, longitudinally extensive myelitis, brainstem, diencephalic, and cerebral syndromes. Up to 80% of NMOSD patients have a circulating pathogenic autoantibody that targets the water channel aquaporin-4 (AQP4-IgG). The discovery of AQP4-IgG transformed our understanding of the pathogenesis of the disease and its possible treatment targets. Monoclonal antibodies targeting terminal complement (eculizumab), CD19 (inebilizumab), and the interl...
Source: BioDrugs - December 10, 2020 Category: Drugs & Pharmacology Source Type: research

Systematic Review and Principal Components Analysis of the Immunogenicity of Adalimumab
ConclusionsFuture studies that evaluate the patient-, product-, and disease-related factors behind the immunogenicity of adalimumab are required because the evidence published so far does not completely explain the temporal increase in immunogenicity rates detected in this analysis. (Source: BioDrugs)
Source: BioDrugs - December 10, 2020 Category: Drugs & Pharmacology Source Type: research

Payer and Implementation Challenges with Advanced Therapy Medicinal Products (ATMPs)
AbstractAdvanced therapy medicinal products (ATMPs) are a dynamic and current topic for healthcare systems, with new products progressing to market at an increasing rate. ATMPs highlight the growing gap between payer and regulator requirements; the limited evidence base combined with pressure to implement rapidly is exacerbating the clinical and financial uncertainties associated with these products. There are a number of key uncertainties with ATMPs related to implementation and healthcare planning —these uncertainties at the time of evaluation have the ability to change the value proposition of products. ATMPs also...
Source: BioDrugs - November 23, 2020 Category: Drugs & Pharmacology Source Type: research

Current and Emerging Targeted Therapies for Acute Graft-Versus-Host Disease
AbstractAcute graft-versus-host disease (GVHD), the major complication after allogeneic hematopoietic cell transplant (HCT), develops in approximately 50% of patients. The primary treatment is high-dose systemic steroids, but treatment failure is common, and steroid-refractory (SR) GVHD is the leading cause of non-relapse mortality after allogeneic HCT. Ruxolitinib became the first treatment for SR GVHD to obtain US  Food and Drug Administration approval, and other new treatments are actively being studied. We searched the literature using the PubMed database and clinical trials using ClinicalTrials.gov to identify th...
Source: BioDrugs - November 17, 2020 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: BioDrugs)
Source: BioDrugs - November 10, 2020 Category: Drugs & Pharmacology Source Type: research

Checkpoint Inhibitors in Gynecological Malignancies: Are we There Yet?
AbstractThe emergence of immune checkpoint inhibitors (ICIs) has revolutionized the field of oncology. For many cancer types, treatment paradigms have changed, as immunotherapy is increasingly being integrated into frontline standard-of-care treatments and producing meaningful and prolonged responses. This has inspired an avalanche of clinical trials studying ICIs in all types of malignancies, including gynecological cancers. Ovarian and endometrial cancers are characterized by DNA damage repair defects, either via disruption of the homologous recombination DNA repair mechanism in the former or via defects in the mismatch ...
Source: BioDrugs - November 3, 2020 Category: Drugs & Pharmacology Source Type: research

European Stakeholder Learnings Regarding Biosimilars: Part I —Improving Biosimilar Understanding and Adoption
ConclusionsThis study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by biosimilar competition. (Source: BioDrugs)
Source: BioDrugs - November 3, 2020 Category: Drugs & Pharmacology Source Type: research

Focused Update on AAV-Based Gene Therapy Clinical Trials for Inherited Retinal Degeneration
AbstractInherited retinal diseases (IRDs) comprise a clinically and genetically heterogeneous group of disorders that can ultimately result in photoreceptor dysfunction/death and vision loss. With over 270 genes known to be involved in IRDs, translation of treatment strategies into clinical applications has been historically difficult. However, in recent years there have been significant advances in basic research findings as well as translational studies, culminating in an increasing number of clinical trials with the ultimate goal of reducing vision loss and associated morbidities. The recent approval of Luxturna® (v...
Source: BioDrugs - November 2, 2020 Category: Drugs & Pharmacology Source Type: research

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study
ConclusionsIn patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755). (Source: BioDrugs)
Source: BioDrugs - October 29, 2020 Category: Drugs & Pharmacology Source Type: research

Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease
AbstractThe inflammatory bowel diseases (IBDs) are chronic immune-mediated inflammatory disorders, including ulcerative colitis (UC) and Crohn ’s disease (CD). IBD results from a complex interplay between environmental, microbial, and genetic factors to create an abnormal immunological response leading to intestinal inflammation. Many pathways driving inflammation have been described, and different pathways may predominate in an individu al patient. The interleukin (IL)-23 pathway plays a key role in IBD pathogenesis through promoting a pathological Th17 response. Targeting IL-23 is effective in the treatment of IBD....
Source: BioDrugs - October 26, 2020 Category: Drugs & Pharmacology Source Type: research

European Stakeholder Learnings Regarding Biosimilars: Part II —Improving Biosimilar Use in Clinical Practice
ConclusionsThis study proposes a number of strategic, practical, and overarching recommendations to support healthcare professionals and inform decision makers to improve the clinical use of biosimilars and the willingness of stakeholders to use them. The proposed solutions to fully realise the potential of biosimilars for healthcare systems and patients include developing practical switch guidance, being transparent about the gains from biosimilar use (and how savings are allocated), and developing a combination of non-tangible and tangible incentives for involved stakeholders. (Source: BioDrugs)
Source: BioDrugs - October 15, 2020 Category: Drugs & Pharmacology Source Type: research

Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?
AbstractItolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 pati...
Source: BioDrugs - October 13, 2020 Category: Drugs & Pharmacology Source Type: research

The Immunotherapy Landscape in Renal Cell Carcinoma
AbstractThe past 30  years have borne witness to a gradual evolution in the treatment landscape of advanced renal cell carcinoma (aRCC). Early immunotherapy approaches such as interferon-α and high-dose interleukin-2 (IL-2) therapy in this immunogenic tumor provided durable responses in only a minority of patients an d came with toxic side effects. A growing understanding of the tumor biology elucidated pathways of tumorigenesis, which in turn revealed novel targets amenable to targeted therapies. Inhibition of angiogenesis and cell signaling emerged as cornerstones of treatment with the approval of bevacizumab ...
Source: BioDrugs - October 13, 2020 Category: Drugs & Pharmacology Source Type: research

Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
AbstractA biosimilar is a biologic drug that is “highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency”. Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the reference product, comparative nonc linical (in vivo) studies, clinical pharmacokinetics and/or pharmacodynamics, and immunogenicity. In addition, comparative clinical efficacy and safety assessments are usually conducted and, taken together, comprise the “totality of the evidence” supporting bio...
Source: BioDrugs - September 28, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials
ConclusionEfficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.Trial RegistrationClinicalTrials.gov, number NCT02148640. (Source: BioDrugs)
Source: BioDrugs - September 22, 2020 Category: Drugs & Pharmacology Source Type: research

PF-06410293: An Adalimumab Biosimilar
AbstractPF-06410293 (Amsparity™/Abrilada™) is a biosimilar of the anti-tumor necrosis factor (TNF)- α antibody adalimumab. It is approved for use in all indications for which adalimumab is approved, including inflammatory joint diseases (e.g. rheumatoid arthritis), uveitis, psoriasis and Crohn’s disease. PF-06410293 has similar physicochemical and pharmacodynamic properties to those of EU- and US-sourced reference adalimumab, and the pharmacokinetic similarity of the agents is supported. PF-06410293 demonstrated therapeutic equivalence to EU-sourced reference adalimumab in patients with rheumatoid a...
Source: BioDrugs - September 18, 2020 Category: Drugs & Pharmacology Source Type: research

Drug Survival of Biologics in Treating Ankylosing Spondylitis: A Systematic Review and Meta-analysis of Real-World Evidence
Conclusion To the best of our knowledge, this study is the first systematic review and meta-analysis on the drug survival of biological therapies for AS patients. The drug survival of all biologics in treating AS appeared comparable, but is higher in first-line biologics than second- and third-line biologics. To date there are scarce data on the drug survival of newly available biologics, for example, anti-interleukin-17 biologics.PROSPERO registration NoCRD42018114204. (Source: BioDrugs)
Source: BioDrugs - September 17, 2020 Category: Drugs & Pharmacology Source Type: research

Changes in Anthropometric Parameters After Anti-TNF α Therapy in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis
ConclusionAnti-TNF α treatment appears to be associated with an increase in body weight, BMI, and other anthropometric parameters. Given the differing courses of IBD between children and adults, this association should be considered before initiating biologics for undernourished, overweight, and obese patients.Registration: PROSPERO registration number CRD42020163079. (Source: BioDrugs)
Source: BioDrugs - September 16, 2020 Category: Drugs & Pharmacology Source Type: research

Monoclonal Antibody-Based Therapies for Myasthenia Gravis
AbstractMyasthenia gravis (MG) is an autoimmune, neuromuscular disorder that produces disabling weakness through a compromise of neuromuscular transmission. The disease fulfills strict criteria of an antibody-mediated disease. Close to 90% of patients have antibodies directed towards the nicotinic acetylcholine receptor (AChR) on the post-synaptic surface of skeletal muscle and another 5% to the muscle-specific kinase, which is involved in concentrating the AChR to the muscle surface of the neuromuscular junction. Conventional treatments of intravenous immunoglobulin and plasma exchange reduce autoantibody levels to produc...
Source: BioDrugs - September 10, 2020 Category: Drugs & Pharmacology Source Type: research

Innovative Therapies for Hemoglobin Disorders
Abstractβ-Globin gene transfer has been used as a paradigm for hematopoietic stem cell (HSC) gene therapy, but is subject to major difficulties, such as the lack of selection of genetically corrected HSCs, the need for high-level expression of the therapeutic gene, and cell-specific transgene expression. I t took more than 40 years for scientists and physicians to advance from the cloning of globin gene and discovering globin gene mutations to improving our understanding of the pathophysiological mechanisms involved, the detection of genetic modifiers, the development of animal models and gene transf er vectors, ...
Source: BioDrugs - September 7, 2020 Category: Drugs & Pharmacology Source Type: research

Cell Therapy for Idiopathic Pulmonary Fibrosis: Rationale and Progress to Date
AbstractIdiopathic pulmonary fibrosis (IPF) is a devastating disease characterized by progressive lung scarring due to unknown injurious stimuli ultimately leading to respiratory failure. Diagnosis is complex and requires a combination of clinical, laboratory, radiological, and histological investigations, along with exclusion of known causes of lung fibrosis. The current understanding of the disease etiology suggests an interaction between genetic factors and epigenetic alterations in susceptible, older individuals. Prognosis is dismal and current treatment options include anti-fibrotic agents that only slow down disease ...
Source: BioDrugs - September 6, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study
Page 215, Section “3.1.2 Primary Structure: Peptide Mapping, Posttranslational Modification (Source: BioDrugs)
Source: BioDrugs - September 3, 2020 Category: Drugs & Pharmacology Source Type: research

Immunotherapy in Breast Cancer: Current Practice and Clinical Challenges
AbstractImmunotherapy is currently approved for a subset of patients diagnosed with advanced triple negative breast cancer (TNBC), based on the phase III randomized controlled trial, IMpassion130. The anti-programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitor atezolizumab combined with nanoparticle albumin-bound (nab)-paclitaxel is currently the standard first-line therapy in patients with metastatic TNBC who have a PD-L1-positive peritumoral immune infiltrate. Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being...
Source: BioDrugs - August 31, 2020 Category: Drugs & Pharmacology Source Type: research

Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015 –2020
AbstractIn the past decades, multiple sclerosis (MS) treatment has experienced vast changes resulting from major advances in disease-modifying therapies (DMT). Looking at the overall number of studies, investigations with therapeutic advantages and encouraging results are exceeded by studies of promising compounds that failed due to either negative or inconclusive results or have been interrupted for other reasons. Importantly, these failed clinical trials are informative experiments that can help us to understand the pathophysiological mechanisms underlying MS. In several trials, concepts taken from experimental models we...
Source: BioDrugs - August 11, 2020 Category: Drugs & Pharmacology Source Type: research

Designer Exosomes: A New Platform for Biotechnology Therapeutics
AbstractDesirable features of exosomes have made them a suitable manipulative platform for biomedical applications, including targeted drug delivery, gene therapy, cancer diagnosis and therapy, development of vaccines, and tissue regeneration. Although natural exosomes have various potentials, their clinical application is associated with some inherent limitations. Recently, these limitations inspired various attempts to engineer exosomes and develop designer exosomes. Mostly, designer exosomes are being developed to overcome the natural limitations of exosomes for targeted delivery of drugs and functional molecules to wou...
Source: BioDrugs - August 3, 2020 Category: Drugs & Pharmacology Source Type: research

Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score –Matched Analysis from the Korean College of Rheumatology Biologics Registry
ConclusionsPropensity score –matching analysis confirmed that CT-P13 treatment was not associated with significant differences in drug retention, treatment duration, most efficacy parameters, or safety versus reference infliximab in Korean patients with ankylosing spondylitis, building evidence for the long-term comparabilit y of these treatments.Trial registrationClinicalTrials.gov identifier: NCT01965132. (Source: BioDrugs)
Source: BioDrugs - July 20, 2020 Category: Drugs & Pharmacology Source Type: research

The Importance of Countering Biosimilar Disparagement and Misinformation
AbstractBiosimilar use is limited in some healthcare systems because biosimilars are not well understood by many healthcare professionals and patients. The knowledge gap is exacerbated by disparagement of biosimilars and dissemination of misinformation, whether intentional or otherwise. There are several different types of disparagement and misinformation directed towards biosimilars as a class, including statements about biosimilar science or policy that are factually incorrect; misleading information, where the information is correct, but is provided out of context; incomplete information, where only partial or a limited...
Source: BioDrugs - July 19, 2020 Category: Drugs & Pharmacology Source Type: research

Update on Biosimilar Insulins: A US Perspective
AbstractThe development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar® (insulin glargine) and Admelog® (insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the op...
Source: BioDrugs - July 16, 2020 Category: Drugs & Pharmacology Source Type: research

Beyond Antibodies: The DARPin ® Drug Platform
AbstractThe DARPin® drug platform was established with a vision to expand the medical use of biologics beyond what was possible with monoclonal antibodies. It is based on naturally occurring ankyrin repeat domains that are typically building blocks of multifunctional human proteins. The platform allows for the generation of diverse, well-behaved, multifunctional drug candidates. Recent clinical data illustrate the favorable safety profile of the first DARPin® molecules tested in patients. With the positive phase III results of the most advanced DARPin® drug candidate, abicipar, the DARPin® drug platform is ...
Source: BioDrugs - June 23, 2020 Category: Drugs & Pharmacology Source Type: research

Potential Role of Anti-interleukin (IL)-6 Drugs in the Treatment of COVID-19: Rationale, Clinical Evidence and Risks
AbstractThe epidemic due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. This public health emergency has triggered a race to find medications to improve the prognosis of this disease. There is currently great interest in drug repositioning to manage SARS-CoV-2 infection, that is, the evaluation of the potential benefits of a drug that has already been proven safe and effective in humans for other approved indications. As interleukin-6 (IL-6) acts as a key driver of the inflammation associated with coronavirus disease 2019 (COVID-19), IL-6 ...
Source: BioDrugs - June 14, 2020 Category: Drugs & Pharmacology Source Type: research

Targeted Therapies for Eosinophilic Gastrointestinal Disorders
AbstractThe growing recognition of eosinophilic gastrointestinal disorders has revealed the limitations of current treatment (mainly based on dietary modification and corticosteroids), and include refractoriness, high recurrence rates, and the need for long-term therapy. Research efforts, mainly in eosinophilic esophagitis (EoE), have unveiled essential pathophysiological mechanisms leading to these disorders, which bear some similarities to those of atopic manifestations and are shared by eosinophilic gastroenteritis (EGE) and eosinophilic colitis (EC). Novel targeted therapies, some imported from bronchial asthma and ato...
Source: BioDrugs - May 28, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Anti-PD-1/PD-L1 in the Treatment of Skin Cancer
AbstractSkin cancers remain the most common group of cancers globally, and the incidence continues to rise. Although localized skin cancers tend to have excellent outcomes following surgical excisions, the less common cases that become surgically unresectable or metastatic have been associated with poor prognosis and suboptimal treatment responses to cytotoxic chemotherapy. Development of monoclonal antibodies to programmed cell death-1 receptor and its ligand (PD-1/PD-L1) have transformed the management of metastatic melanoma, squamous cell carcinoma, and Merkel cell carcinoma. These agents, as monotherapies, are associat...
Source: BioDrugs - May 22, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
The article MYL1501D Insulin Glargine: A Review in Diabetes Mellitus, written by Sheridan M. (Source: BioDrugs)
Source: BioDrugs - May 11, 2020 Category: Drugs & Pharmacology Source Type: research

Pseudoprogression and Hyperprogression as New Forms of Response to Immunotherapy
In conclusion, pseudoprogression and hyperprogression are both frequent types of responses under immunotherapy, and there is a need to better characterize these to improve the management of cancer patients. Treatment beyond progression should always be considered with caution and necessitates close clinical monitoring. In case of suspected hyperprogression, immunotherapy should be stopped early. (Source: BioDrugs)
Source: BioDrugs - May 10, 2020 Category: Drugs & Pharmacology Source Type: research

Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies
ConclusionThe CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment. (Source: BioDrugs)
Source: BioDrugs - April 29, 2020 Category: Drugs & Pharmacology Source Type: research

Applying Antibodies Inside Cells: Principles and Recent Advances in Neurobiology, Virology and Oncology
AbstractTo interfere with cell function, many scientists rely on methods that target DNA or RNA due to the ease with which they can be applied. Proteins are usually the final executors of function but are targeted only indirectly by these methods. Recent advances in targeted degradation of proteins based on proteolysis-targeting chimaeras (PROTACs), ubiquibodies, deGradFP (degrade Green Fluorescent Protein) and other approaches have demonstrated the potential of interfering directly at the protein level for research and therapy. Proteins can be targeted directly and very specifically by antibodies, but using antibodies ins...
Source: BioDrugs - April 15, 2020 Category: Drugs & Pharmacology Source Type: research

The Path Towards a Tailored Clinical Biosimilar Development
AbstractSince the first approval of a biosimilar medicinal product in 2006, scientific understanding of the features and development of biosimilar medicines has accumulated. This review scrutinizes public information on development programs and the contribution of the clinical studies for biosimilar approval in the European Union (EU) and/or the United States (US) until November 2019. The retrospective evaluation of the programs that eventually obtained marketing authorization and/or licensure revealed that in 95% (36 out of 38) of all programs, the comparative clinical efficacy studies confirmed similarity. In the remaini...
Source: BioDrugs - April 6, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
The article Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study, written by Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning and Rita L. Hui, was originally published electronically on 26 February 2020 without open access. (Source: BioDrugs)
Source: BioDrugs - April 5, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Immune Checkpoint Inhibitors in Colorectal Adenocarcinoma
AbstractOver the past decade, immune checkpoint inhibitors (ICI) have proven to be promising agents in a number of solid tumor malignancies. Pembrolizumab and nivolumab are ICIs that target programmed cell death protein  1 and both have been approved by the US Food and Drug Administration for the treatment of microsatellite instability-high/DNA mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC). In MSI-H/dMMR CRC, these agents were found to have considerable antitumor activity and are now used in the t reatment of this disease. However, MSI-H/dMMR tumors account for only 5% of metastatic CRC and the remain...
Source: BioDrugs - April 2, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies
The article In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies, written by Ami Patel, Mamadou A. Bah and David B. (Source: BioDrugs)
Source: BioDrugs - April 1, 2020 Category: Drugs & Pharmacology Source Type: research

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure
AbstractFebrile neutropenia (FN) is a serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions and, ultimately, reduce cancer survival. Over the past decade, the availability of biosimilar filgrastim (short-acting granulocyte colony-stimulating factor [G-CSF]) has transformed patient access, with clear evidence of clinical benefit at preventing FN at reduced costs. In 2019, seven biosimilar pegfilgrastims (long-acting G-CSFs) were licensed, creating optimal market conditions and choice for prescribers. FN affects up to 117 per 1000 cancer patients, with...
Source: BioDrugs - March 29, 2020 Category: Drugs & Pharmacology Source Type: research

MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
AbstractSubcutaneous MYL1501D insulin glargine 100  U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee®] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100  U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus®] in various countries, including those of the EU for the treatment of diabetes mellitus in patients aged  ≥ 2 years, as well as Japan for diabetes where insulin therapy is indicated. MYL1501D insulin glargine has similar physicochemical characteristics and biological properties to those of EU- an...
Source: BioDrugs - March 24, 2020 Category: Drugs & Pharmacology Source Type: research

Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis
AbstractCertolizumab pegol (Cimzia®) is a PEGylated, Fab ′-only, recombinant humanized antibody against TNF-α. Subcutaneous certolizumab pegol is indicated for the treatment of various immune-mediated inflammatory diseases (IMIDs), including moderate to severe plaque psoriasis. In pivotal phase III trials in adults with moderate to severe plaque psoria sis, significantly more patients receiving certolizumab pegol 200 mg or 400 mg once every 2 weeks than placebo recipients achieved a ≥ 75% reduction in PASI score (PASI75 responder) and a PGA score of clear/mostly clear with a&...
Source: BioDrugs - March 22, 2020 Category: Drugs & Pharmacology Source Type: research

Ongoing Developments and Clinical Progress in Drug-Loaded Red Blood Cell Technologies
AbstractEngineered red blood cells (RBCs) appear to be a promising method for therapeutic drug and protein delivery. With a number of agents in clinical trials (e.g., dexamethasone 21-phosphate in ataxia telangiectasia, asparaginase in pancreatic cancer/acute lymphoblastic leukemia, thymidine phosphorylase in mitochondrial neurogastrointestinal encephalomyopathy, RTX-134 in phenylketonuria, etc.), this leading article summarizes the ongoing efforts in developing these agents, focuses on the clinical progress, and provides a brief background into engineered RBCs and the different ways in which they can be exploited for ther...
Source: BioDrugs - March 19, 2020 Category: Drugs & Pharmacology Source Type: research

Cell-Free Protein Synthesis: A Promising Option for Future Drug Development
AbstractProteins are the main source of drug targets and some of them possess therapeutic potential themselves. Among them, membrane proteins constitute approximately 50% of the major drug targets. In the drug discovery pipeline, rapid methods for producing different classes of proteins in a simple manner with high quality are important for structural and functional analysis. Cell-free systems are emerging as an attractive alternative for the production of proteins due to their flexible nature without any cell membrane constraints. In a bioproduction context, open systems based on cell lysates derived from different source...
Source: BioDrugs - March 19, 2020 Category: Drugs & Pharmacology Source Type: research