1,109 results match your criteria BioDrugs[Journal]


Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS).

BioDrugs 2018 Jun 5. Epub 2018 Jun 5.

Department of Pharmacy, Pharmaceutical Sciences Postgraduate Research Program, Federal University of Paraná, Curitiba, Brazil.

Introduction: The molecular and pharmacological complexity of biologic disease-modifying antirheumatic drugs used for the management of rheumatoid arthritis (RA) favors the occurrence of adverse drug reactions (ADRs), which should be constantly monitored in post-marketing safety studies.

Objective: The aim of this study was to identify signals of disproportionate reporting (SDR) of clinical relevance related to the use of biologic drugs approved for RA and other autoimmune diseases.

Methods: All suspected ADRs registered in the FDA Adverse Event Reporting System between January 2003 and June 2016 were collected. Read More

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June 2018
1 Read

Determining the Value of Two Biologic Drugs for Chronic Inflammatory Skin Diseases: Results of a Multi-Criteria Decision Analysis.

BioDrugs 2018 Jun;32(3):281-291

Fundación Weber, Majadahonda, Madrid, Spain.

Background And Objective: Multi-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain.

Method: Following the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Read More

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SB3 (Ontruzant): A Trastuzumab Biosimilar.

Authors:
Yvette N Lamb

BioDrugs 2018 Jun;32(3):293-296

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

SB3 (Ontruzant) is the first biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, namely HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. SB3 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy volunteers and women with HER2-positive early or locally advanced breast cancer. Read More

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Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review.

BioDrugs 2018 Jun;32(3):193-199

Organización Médica de Investigación, Buenos Aires, Argentina.

Objective: Regulatory approval of biosimilar versions of originator biotherapeutics requires that new biological products be highly similar to originator products, with no clinically meaningful differences in safety, purity, and potency. In some trials of biosimilars of tumor necrosis factor inhibitors for the treatment of rheumatoid arthritis (RA) and plaque psoriasis (PsO), pre-specified margins for efficacy and safety have been met, but differences in treatment responses between pivotal originator trials and biosimilar trials have been noted. The objective of this systematic review was to examine these differences. Read More

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Anticalin Proteins as Therapeutic Agents in Human Diseases.

BioDrugs 2018 Jun;32(3):233-243

Lehrstuhl für Biologische Chemie, Technische Universität München, Emil-Erlenmeyer-Forum 5, 85354, Freising (Weihenstephan), Germany.

Anticalin proteins are an emerging class of clinical-stage biopharmaceuticals with high potential as an alternative to antibodies. Anticalin molecules are generated by combinatorial design from natural lipocalins, which are abundant plasma proteins in humans, and reveal a simple, compact fold dominated by a central β-barrel, supporting four structurally variable loops that form a binding site. Reshaping of this loop region results in Anticalin proteins that can recognize and tightly bind a wide range of medically relevant targets, from small molecules to peptides and proteins, as validated by X-ray structural analysis. Read More

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Therapeutic Targeting of the Interleukin-4/Interleukin-13 Signaling Pathway: In Allergy and Beyond.

BioDrugs 2018 May 7. Epub 2018 May 7.

Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, 69978, Tel-Aviv, Israel.

Inflammation triggered by interleukin-4 (IL-4)/IL-13 is mediated by IL-4 and IL-13 receptors that are present on multiple cell types, including epithelial cells, smooth muscle, fibroblasts endothelial cells and immune cells. IL-4 exerts its activities by interacting with two specific cell surface receptors: one designated the type 1 IL-4 receptor (IL-4R); the other designated the type 2 IL-4R, a receptor complex that is also the functional receptor for IL-13. "Traditionally," IL-4 and IL-13 have been studied in the context of T helper 2-associated immune responses (i. Read More

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Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

BioDrugs 2018 Jun;32(3):267-280

School of Pharmacy, University College Cork, Cork, Ireland.

Background: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines.

Objective: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Read More

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Tissue Engineering in Osteoarthritis: Current Status and Prospect of Mesenchymal Stem Cell Therapy.

Authors:
Gun-Il Im

BioDrugs 2018 Jun;32(3):183-192

Department of Orthopaedics, Research Institute for Integrative Regenerative Medical Engineering, Dongguk University Ilsan Hospital, 814 Siksa-Dong, Goyang, 410-773, Republic of Korea.

Osteoarthritis (OA) is the most common form of arthritis. Over the last 20 years, attempts have been made to regenerate articular cartilage to overcome the limitations of conventional treatments. As OA is generally associated with larger and diffuse involvement of articular surfaces and alteration of joint homeostasis, a tissue engineering approach for cartilage regeneration is more difficult than in simple chondral defects. Read More

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Overcoming Tumor-Induced Immune Suppression: From Relieving Inhibition to Providing Costimulation with T Cell Agonists.

BioDrugs 2018 Jun;32(3):221-231

Earle A. Chiles Research Institute, Providence Portland Medical Center, 4805 NE Glisan St., 2N35, Portland, OR, 97213, USA.

Recent advancements in T-cell biology and antibody engineering have opened doors to significant improvements in cancer immunotherapy. Initial success with monoclonal antibodies targeting key receptors that inhibit T-cell function such as cytotoxic T lymphocyte antigen 4 (CTLA-4) and programmed death-ligand 1 (PD-1) have demonstrated the potency of this new class of therapy, highlighted by long-term complete responses for metastatic cancers once thought incurable. However, only a subset of patients responds to checkpoint blockade because of a multitude of factors, including an immunosuppressive tumor microenvironment and the mutational burden of the cancer. Read More

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June 2018
2 Reads

Benefit Versus Risk Assessment of Rotavirus Vaccination in France: A Simulation and Modeling Analysis.

BioDrugs 2018 Apr;32(2):139-152

Pharmaco-Epidemiology and Health Outcomes Research, Laboratoire GSK, Rueil-Malmaison, France.

Introduction: Two vaccines against rotavirus gastroenteritis (RVGE) in young children, Rotarix and RotaTeq, have been available in Europe since 2006. Vaccination against rotaviruses significantly reduces the burden of RVGE, but it is also associated with a very small increased risk of intussusception. In a benefit-risk analysis, the prevented RVGE burden is weighed against the possible excess of intussusception. Read More

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April 2018
7 Reads

Humanized Mouse Models for the Preclinical Assessment of Cancer Immunotherapy.

BioDrugs 2018 Jun;32(3):245-266

Department of Gynecology and Obstetrics, University Medical Center Regensburg, Landshuter Straße 65, 93053, Regensburg, Germany.

Immunotherapy is one of the most exciting recent breakthroughs in the field of cancer treatment. Many different approaches are being developed and a number have already gained regulatory approval or are under investigation in clinical trials. However, learning from the past, preclinical animal models often insufficiently reflect the physiological situation in humans, which subsequently causes treatment failures in clinical trials. Read More

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June 2018
2 Reads

Comprehensive Physicochemical and Biological Characterization of the Proposed Biosimilar Darbepoetin Alfa, LBDE, and Its Originator Darbepoetin Alfa, NESP.

BioDrugs 2018 Apr;32(2):153-168

Department of Biological Sciences, KAIST, 291 Daehak-ro, Yuseong-gu, Daejeon, 34141, Republic of Korea.

Background: For regulatory approval, the comparability of a biosimilar product to an originator product should be ensured through thorough physicochemical and biological characterization.

Objective: To evaluate the biosimilarity between LBDE, the proposed biosimilar darbepoetin alfa, and NESP, its originator, we performed a comprehensive physicochemical and biological characterization study.

Methods: Primary and higher-order protein structures were analyzed using Lys-C peptide mapping with liquid chromatography-mass spectrometry (LC-MS), disulfide bond identification, circular dichroism, and fluorescence spectroscopy. Read More

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April 2018
2 Reads

Interleukin-1 Blockade in Cardiovascular Diseases: From Bench to Bedside.

BioDrugs 2018 Apr;32(2):111-118

VCU Pauley Heart Center, Virginia Commonwealth University, 1200 E Broad St, Box 980204, Richmond, VA, 23298, USA.

Interleukin-1 (IL-1) is the prototypical pro-inflammatory cytokine that occupies an apical place in the inflammatory cascade and also modulates cardiac function, functioning as a soluble cardiodepressant factor. Preclinical research over the past 4 decades has shown that blocking IL-1 processing or activity favorably affects cardiomyocyte survival and cardiac function in experimental animal models, paving the way for clinical studies in patients with heart disease. The promising results of phase II clinical trials of IL-1 blockade in patients with acute myocardial infarction and heart failure have been followed by a successful phase III trial in patients with prior acute myocardial infarction. Read More

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April 2018
2 Reads

Authors' Reply to Dr. Riccardo Perfetti: "LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes".

BioDrugs 2018 Apr;32(2):179

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

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April 2018
2 Reads

Comment on: LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes.

BioDrugs 2018 Apr;32(2):177

Sanofi, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.

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April 2018
3 Reads

Targeting Neoantigens for Personalised Immunotherapy.

BioDrugs 2018 Apr;32(2):99-109

Genetics and Immunology Research Group, An Lòchran, 10 Inverness Campus, Inverness, IV2 5NA, Scotland, UK.

This review discusses the rapidly evolving field of immunotherapy research, focusing on the types of cancer antigens that can be recognised by the immune system and potential methods by which neoantigens can be exploited clinically to successfully target and clear tumour cells. Recent studies suggest that the likelihood of successful immunotherapeutic targeting of cancer will be reliant on immune response to neoantigens. This type of cancer-specific antigen arises from somatic variants that result in alteration of the expressed protein sequence. Read More

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April 2018
1 Read

Correction to: LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes.

BioDrugs 2018 Apr;32(2):181

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

Page 91, abstract, lines 1-6: The following sentence, which previously read. Read More

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April 2018
2 Reads

Correction to: Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained.

BioDrugs 2018 Apr;32(2):137-138

Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.

Figure 1, HX575 column, 5th box down, which previously read "SC HX575 vs. Eprex/Erypo 417 patients with CKD-related anemia" as shown here. Read More

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April 2018
2 Reads

Guselkumab for the Treatment of Psoriasis.

BioDrugs 2018 Apr;32(2):119-128

Department of Dermatology, Centro Hospitalar do Porto, Porto, Portugal.

Psoriasis is a common, chronic, immune-mediated, inflammatory skin disease with systemic involvement and significant impact on patients' quality of life. Several biologic treatments have been developed in recent decades, such as tumor necrosis factor (TNF)-α inhibitors, a non-selective interleukin (IL)-23 inhibitor (ustekinumab, which also inhibits IL-12), and-most recently-IL-17 inhibitors. Guselkumab is a novel biological therapy that selectively targets IL-23 and is the first-in-class selective IL-23 inhibitor approved to treat moderate-to-severe plaque psoriasis. Read More

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April 2018
1 Read

Plasma Pharmacokinetics of Valanafusp Alpha, a Human Insulin Receptor Antibody-Iduronidase Fusion Protein, in Patients with Mucopolysaccharidosis Type I.

BioDrugs 2018 Apr;32(2):169-176

ArmaGen, Inc., Calabasas, CA, USA.

Background: Mucopolysaccharidosis type I (MPSI) is caused by mutations in the gene encoding the α-L-iduronidase (IDUA) lysosomal enzyme and the majority of MPSI patients have severe central nervous system (CNS) involvement. Enzyme replacement therapy (ERT) with recombinant IDUA does not treat the CNS, due to the lack of transport of the enzyme across the blood-brain barrier (BBB). Human IDUA has been re-engineered as an IgG-IDUA fusion protein, valanafusp alpha, where the IgG domain is a monoclonal antibody (MAb) against the human insulin receptor (HIR). Read More

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April 2018
3 Reads

Recombinant Human PH20: Baseline Analysis of the Reactive Antibody Prevalence in the General Population Using Healthy Subjects.

BioDrugs 2018 Feb;32(1):83-89

Immunology and Cell Biology, Halozyme Therapeutics, Inc., 11388 Sorrento Valley Road, San Diego, CA, 92121, USA.

Background: Recombinant human PH20 (rHuPH20) is used to depolymerize hyaluronan in the subcutaneous space, increasing the dispersion and absorption of co-administered drugs. While ~ 5 to 10% of rHuPH20 treatment-naïve healthy volunteers have demonstrated rHuPH20-reactive antibodies, associations with age, sex, fertility, and immune disorders remain unknown.

Objectives: Using demographically diverse healthy volunteers, we assessed the prevalence of rHuPH20-reactive antibodies in the general population and potential associations with fertility and autoimmunity diseases. Read More

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February 2018
2 Reads

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained.

BioDrugs 2018 Apr;32(2):129-135

Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.

High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Read More

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April 2018
2 Reads

Codon Optimization in the Production of Recombinant Biotherapeutics: Potential Risks and Considerations.

Authors:
Vincent P Mauro

BioDrugs 2018 Feb;32(1):69-81

The Scripps Research Institute, La Jolla, CA, 92037, USA.

Biotherapeutics are increasingly becoming the mainstay in the treatment of a variety of human conditions, particularly in oncology and hematology. The production of therapeutic antibodies, cytokines, and fusion proteins have markedly accelerated these fields over the past decade and are probably the major contributor to improved patient outcomes. Today, most protein therapeutics are expressed as recombinant proteins in mammalian cell lines. Read More

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February 2018
3 Reads

Applications of Bioengineered 3D Tissue and Tumor Organoids in Drug Development and Precision Medicine: Current and Future.

BioDrugs 2018 Feb;32(1):53-68

Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27101, USA.

Over the past decade, advances in biomedical and tissue engineering technologies, such as cell culture techniques, biomaterials, and biofabrication, have driven increasingly widespread use of three-dimensional (3D) cell culture platforms and, subsequently, the use of organoids in a variety of research endeavors. Given the 3D nature of these organoid systems, and the frequent inclusion of extracellular matrix components, these constructs typically have more physiologically accurate cell-cell and cell-matrix interactions than traditional 2D cell cultures. As a result, 3D organoids can serve as better model systems than their 2D counterparts. Read More

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February 2018
5 Reads

LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes.

BioDrugs 2018 Feb;32(1):91-98

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

Subcutaneous once-daily LY2963016 insulin glargine (LY insulin glargine) [Abasaglar (EU); Basaglar (USA)] has been approved in the EU as a biosimilar to reference insulin glargine (Lantus), and in the USA as a follow-on biologic to reference insulin glargine, for use in patients with type 1 or 2 diabetes. Structural and functional characterization of LY insulin glargine in preclinical studies showed that it is similar to reference insulin glargine. In phase I euglycaemic clamp studies, LY insulin glargine demonstrated similar pharmacodynamic (including duration of action) and pharmacokinetic parameters to reference insulin glargine. Read More

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February 2018
3 Reads

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

BioDrugs 2018 Feb;32(1):27-52

Mater Research Institute, University of Queensland, Brisbane, QLD, Australia.

Background: The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern.

Objectives: The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps.

Methods: A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Read More

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February 2018
8 Reads

Therapeutic Cancer Vaccines: How Much Closer Are We?

Authors:
Douglas G McNeel

BioDrugs 2018 Feb;32(1):1-7

7007 Wisconsin Institutes for Medical Research, University of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.

The promise of immune-based therapies to treat cancer has been realized over the last several years with several breakthrough therapies, including T-cell checkpoint inhibitors and chimeric antigen receptor (CAR)-T cell therapies. While cancer vaccines have been investigated for many decades, to date only one has been approved in the USA as a treatment for existing cancer. The failure of several anti-tumor vaccines in large phase III trials has led many to question their future role in cancer treatment. Read More

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February 2018
3 Reads

Next-Generation Chimeric Antigen Receptor T-Cell Therapy: Going off the Shelf.

BioDrugs 2017 Dec;31(6):473-481

Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.

Autologous, patient-specific chimeric antigen receptor T-cell (CART) therapy has emerged as a powerful and potentially curative therapy for cancer, especially for CD19-positive hematological malignancies. Indeed, on August 30, 2017, the University of Pennsylvania-designed CD19-directed CART (CART-19) cell therapy (CTL019, tisagenlecleucel-t, Kymriah - Novartis) became the first CART therapy approved by the Food and Drug Administration (FDA) for acute lymphoblastic leukemia. However, the development of CART technology and its wider application is partly limited by the patient-specific nature of such a platform and by the time required for manufacturing. Read More

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December 2017
5 Reads

Impact of Infliximab and Etanercept Biosimilars on Biological Disease-Modifying Antirheumatic Drugs Utilisation and NHS Budget in the UK.

BioDrugs 2017 Dec;31(6):533-544

School of Pharmacy, Keele University, Hornbeam Building 3.06, Newcastle-under-Lyme, Staffordshire, ST5 5BG, UK.

Objective: Biological disease-modifying antirheumatic drugs (bDMARDs) are effective but expensive options for treating rheumatoid arthritis. The introduction of infliximab and etanercept biosimilars presents a significant potential cost saving in a financially constrained health system such as the National Health Service (NHS) in the UK. This study examines the impact of the introduction of infliximab and etanercept biosimilars on the utilisation of bDMARDs and subsequent budget impact. Read More

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December 2017
3 Reads

Gene Therapy for Hemophilia: Progress to Date.

BioDrugs 2018 Feb;32(1):9-25

Shire, 650 Kendall Drive, Cambridge, MA, 02142, USA.

Hemophilia is a congenital bleeding disorder that affects nearly half a million individuals worldwide. Joint bleeding and other co-morbidities are a significant source of debilitation for this population. Current therapies are effective but must be given lifelong at regular intervals, are costly, and are available to only about 25% of the hemophilia population living in resource-rich countries. Read More

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February 2018
5 Reads

The Application of CGRP(r) Monoclonal Antibodies in Migraine Spectrum: Needs and Priorities.

BioDrugs 2017 Dec;31(6):483-485

Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.

Migraine is among the highest impact illnesses in the global population. Its negative ramifications are personal, social, economic and work related. Research on the development of new preventative migraine therapies has been idle for decades. Read More

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December 2017
4 Reads

Recent Developments in ADC Technology: Preclinical Studies Signal Future Clinical Trends.

BioDrugs 2017 Dec;31(6):521-531

Catalent Biologics, 5703 Hollis Street, Emeryville, CA, 94608, USA.

The antibody-drug conjugate (ADC) field is in a transitional period. Older approaches to conjugate composition and dosing regimens still dominate the ADC clinical pipeline, but preclinical work is driving a rapid evolution in how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes. These advances are largely based upon a body of investigational studies that together offer a deeper understanding of the absorption, distribution, metabolism, and excretion (ADME) and drug metabolism and pharmacokinetics (DMPK) fates of both the intact conjugate and its small-molecule component. Read More

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December 2017
2 Reads

CGRP Monoclonal Antibodies for Migraine: Rationale and Progress.

BioDrugs 2017 Dec;31(6):487-501

Jefferson Headache Center, Thomas Jefferson University, 900 Walnut Street, Suite 200, Philadelphia, PA, 19107, USA.

Calcitonin gene-related peptide (CGRP), a neuropeptide abundant in the trigeminal system and widely expressed in both the peripheral and central nervous systems, has recently emerged as a promising target for migraine management. While known as a potent arterial vasodilator, the role of CGRP in migraine is likely mediated by modulating nociception and sustaining neurogenic inflammation that leads to further peripheral and central pain sensitization. Functional blockade of CGRP, which involves either CGRP receptor antagonists or monoclonal antibodies (mAbs) to CGRP or its receptor, has recently shown clinical efficacy in migraine management. Read More

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December 2017
3 Reads

Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants.

BioDrugs 2017 Dec;31(6):545-554

Eli Lilly and Company, Indianapolis, IN, USA.

Background: Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis.

Objective: The objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noninferior to control.

Methods: In a randomized, open-label, parallel-group study, adult subjects received vaccinations alone (N = 42, control) or in combination with 160 mg IXE subcutaneously 2 weeks prior to vaccination and 80 mg IXE on the day of vaccination (N = 41, IXE). Read More

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December 2017
5 Reads

Delivery of Biologics Across the Blood-Brain Barrier with Molecular Trojan Horse Technology.

BioDrugs 2017 Dec;31(6):503-519

ArmaGen, Inc., 26679 Agoura Road, Calabasas, CA, 91302, USA.

Biologics are potential new therapeutics for many diseases of the central nervous system. Biologics include recombinant lysosomal enzymes, neurotrophins, decoy receptors, and therapeutic antibodies. These are large molecule drugs that do not cross the blood-brain barrier (BBB). Read More

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December 2017
4 Reads

GP2015: An Etanercept Biosimilar.

Authors:
Emma D Deeks

BioDrugs 2017 Dec;31(6):555-558

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

GP2015 is the second biosimilar of the reference p75 TNF receptor-Fc fusion protein etanercept. It is approved for use in all indications for which reference etanercept is approved, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. GP2015 has similar physiochemical and pharmacodynamic properties to those of reference etanercept, and the pharmacokinetic biosimilarity of the agents has been shown in healthy volunteers. Read More

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December 2017
13 Reads

Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists.

BioDrugs 2017 Oct;31(5):447-459

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, O&N2, Herestraat 49, Box 521, 3000, Leuven, Belgium.

Background: Among patients and rheumatologists, current knowledge and perception of biosimilars in comparison with originator biologics is unknown.

Objectives: The aim of this study was to investigate this knowledge and perception in Belgian rheumatologists and rheumatoid arthritis (RA) patients.

Methods: Anonymous web surveys were conducted in Belgian RA patients (n = 121) and rheumatologists (n = 41) during the period January-March 2016. Read More

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October 2017
6 Reads

GP2013: A Rituximab Biosimilar.

Authors:
Hannah A Blair

BioDrugs 2017 Oct;31(5):465-468

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

GP2013 is the second biosimilar of the reference monoclonal anti-CD20 antibody rituximab to be approved in the EU. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. GP2013 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA. Read More

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October 2017
7 Reads

Asthma Phenotypes and Endotypes: Implications for Personalised Therapy.

BioDrugs 2017 Oct;31(5):393-408

Manchester Academic Health Science Centre, The University of Manchester and University Hospital South Manchester, Manchester, UK.

Asthma is increasingly recognised as a heterogeneous group of diseases with similar clinical presentations rather than a singular disease entity. Asthma was historically categorised by clinical symptoms; however, newer methods of subgrouping, describing and categorising the disease have sub-defined asthma. These sub-definitions are intermittently called phenotypes or endotypes, but the real meanings of these words are poorly understood. Read More

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October 2017
8 Reads

Advances in the Application and Impact of MicroRNAs as Therapies for Skin Disease.

BioDrugs 2017 Oct;31(5):423-438

Biocogent, LLC, 25 Health Sciences Drive, Stony Brook, NY, 11790, USA.

The advent of RNA interference (RNAi) technology has profoundly impacted molecular biology research and medicine but has also advanced the field of skin care. Both effector molecules of RNAi, short-interfering RNA molecules and microRNAs (miRNAs), have been explored for their relative impact and utility for treating a variety of skin conditions. These post-transcriptional RNA regulatory molecules down-modulate protein expression through targeting of the 3' untranslated regions of messenger RNAs, leading to their degradation or repression through sequestration. Read More

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October 2017
4 Reads

Monoclonal Antibodies for Atopic Dermatitis: Progress and Potential.

BioDrugs 2017 Oct;31(5):409-422

Departments of Dermatology, Preventive Medicine and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.

Atopic dermatitis (AD) is a complex and heterogeneous inflammatory skin disorder with a profound symptom and lesional burden. Moderate-to-severe AD is particularly challenging to manage, as topical treatments are often inadequate and the systemic immunosuppressants are limited by concerns of toxicity and tolerability. Recent AD research has elucidated the mechanisms and immunologic factors involved in AD pathogenesis. Read More

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October 2017
4 Reads

Metabolic Enzymes in Sarcomagenesis: Progress Toward Biology and Therapy.

BioDrugs 2017 Oct;31(5):379-392

Department of Medicine, Division of Medical Oncology, University of Miami Miller School of Medicine, Miami, FL, USA.

Cellular metabolism reprogramming is an emerging hallmark of cancer, which provides tumor cells with not only necessary energy but also crucial materials to support growth. Exploiting the unique features of cancer metabolism is promising in cancer therapies. The growing interest in this field has led to numerous inhibitors being developed against key molecules in metabolic pathways, though most of them are still in preclinical development. Read More

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October 2017
10 Reads

SB2: An Infliximab Biosimilar.

BioDrugs 2017 Oct;31(5):461-464

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Read More

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October 2017
11 Reads

Erratum to: A 'Global Reference' Comparator for Biosimilar Development.

BioDrugs 2017 Aug;31(4):287

FDA Regulatory Strategy and Policy, Avalere Inc, 1350 Connecticut Avenue, NW, Suite 900, Washington, DC, 20036, USA.

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August 2017
13 Reads

Patients' Understanding and Attitudes Towards Infliximab and Etanercept Biosimilars: Result of a UK Web-Based Survey.

BioDrugs 2017 Oct;31(5):439-446

School of Pharmacy, Keele University, Hornbeam Building 3.06, Newcastle-under-Lyme, Staffordshire, ST5 5BG, UK.

Background: Infliximab and etanercept biosimilars present significant potential cost savings to the NHS. Patients need to be involved in the decision to use these medicines but there is limited published literature on their knowledge and attitudes about these biosimilars.

Objectives: The aim of this study was to investigate ankylosing spondylitis and rheumatoid arthritis patients' knowledge and attitudes towards infliximab and etanercept biosimilars in the UK. Read More

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October 2017
6 Reads

Adeno-Associated Virus (AAV) as a Vector for Gene Therapy.

BioDrugs 2017 Aug;31(4):317-334

BiStro Biotech Consulting, LLC, Bridgewater, NJ, 08807, USA.

There has been a resurgence in gene therapy efforts that is partly fueled by the identification and understanding of new gene delivery vectors. Adeno-associated virus (AAV) is a non-enveloped virus that can be engineered to deliver DNA to target cells, and has attracted a significant amount of attention in the field, especially in clinical-stage experimental therapeutic strategies. The ability to generate recombinant AAV particles lacking any viral genes and containing DNA sequences of interest for various therapeutic applications has thus far proven to be one of the safest strategies for gene therapies. Read More

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August 2017
14 Reads

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs 2017 Aug;31(4):299-316

Medical Affairs, Pfizer, Collegeville, PA, USA.

Objectives: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety.

Methods: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis.

Results: Of >21,000 screened publications, 443 were included. Read More

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August 2017
20 Reads

Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial.

BioDrugs 2017 Aug;31(4):357-367

School of Medicine, IN-HA University, Incheon, Republic of Korea.

Background: CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents.

Objective: Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks.

Methods: In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2. Read More

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August 2017
16 Reads

Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis.

BioDrugs 2017 Aug;31(4):369-377

Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea.

Background: CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884).

Objective: This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i. Read More

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August 2017
23 Reads

LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects.

BioDrugs 2017 Aug;31(4):349-355

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.

Objectives: We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel, the reference biological product.

Methods: A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Read More

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August 2017
35 Reads