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    Plasma Pharmacokinetics of Valanafusp Alpha, a Human Insulin Receptor Antibody-Iduronidase Fusion Protein, in Patients with Mucopolysaccharidosis Type I.
    BioDrugs 2018 Feb 13. Epub 2018 Feb 13.
    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

    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

    Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained.
    BioDrugs 2018 Feb 7. Epub 2018 Feb 7.
    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

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

    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

    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

    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

    Therapeutic Cancer Vaccines: How Much Closer Are We?
    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

    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

    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

    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

    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

    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

    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

    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

    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

    GP2015: An Etanercept Biosimilar.
    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

    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

    GP2013: A Rituximab Biosimilar.
    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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) ( 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

    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 Enbrelwas subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Read More

    Targeting Sclerostin in Postmenopausal Osteoporosis: Focus on Romosozumab and Blosozumab.
    BioDrugs 2017 Aug;31(4):289-297
    Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand.
    Most current treatments for osteoporosis inhibit bone resorption and reduce total fracture numbers by about one-quarter. The identification of the osteocytic protein sclerostin as a potent regulator of bone turnover and bone density has led to the development of a new therapeutic class-agents that inhibit sclerostin activity, resulting in increased bone formation and reduced bone resorption. Romosozumab and blosozumab are monoclonal antibodies that bind to sclerostin, reducing its inhibition of Wnt signaling. Read More

    Cell-Based Therapies with T Regulatory Cells.
    BioDrugs 2017 Aug;31(4):335-347
    Department of Clinical Immunology and Transplantology, Medical University of Gdańsk, Dębinki 7, 80-210, Gdańsk, Poland.
    CD4CD25FoxP3T regulatory cells (Tregs) are immunodominant suppressors in the immune system. Tregs use various mechanisms to control immune responses. Preclinical data from animal models have confirmed the huge therapeutic potential of Tregs in many immune-mediated diseases. Read More

    Rituximab for Steroid-Dependent or Frequently Relapsing Idiopathic Nephrotic Syndrome in Adults: A Retrospective, Multicenter Study in Spain.
    BioDrugs 2017 Jun;31(3):239-249
    Glomerular Renal Diseases, Nephrology Department, Fundació Puigvert, Cartagena 340-350, 08025, Barcelona, Spain.
    Background: Patients with difficult-to-treat idiopathic nephrotic syndrome (INS), steroid-dependent nephrotic syndrome (SDNS), or frequently relapsing nephrotic syndrome (FRNS) require long-term immunosuppressive therapy. Rituximab offers an alternative treatment for patients with disease that has not responded to multiple therapies.

    Objective: Our objective was to determine the efficacy and safety of rituximab in adult patients with difficult-to-treat (SDNS or FRNS) INS. Read More

    Golimumab: A Review in Inflammatory Arthritis.
    BioDrugs 2017 Jun;31(3):263-274
    Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
    Golimumab (Simponi), a fully human monoclonal antibody against tumour necrosis factor-alpha (TNFα), is given once monthly by subcutaneous injection. In the EU, golimumab is approved as monotherapy and/or in combination with methotrexate for the treatment of inflammatory arthritis, including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis [comprising ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)] in adults, and polyarticular juvenile idiopathic arthritis (pJIA) in children. These approvals were based on the observations that golimumab was generally well tolerated and conferred some or all of the following benefits in pivotal studies in these settings: reduced signs and symptoms of arthritis; improved physical functioning and health-related quality of life; and slowed radiographic progression. Read More

    A 'Global Reference' Comparator for Biosimilar Development.
    BioDrugs 2017 Aug;31(4):279-286
    FDA Regulatory Strategy and Policy, Avalere Inc, 1350 Connecticut Avenue, NW, Suite 900, Washington, DC, 20036, USA.
    Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process. Read More

    Biological Safety of a Highly Purified 10% Liquid Intravenous Immunoglobulin Preparation from Human Plasma.
    BioDrugs 2017 Jun;31(3):251-261
    LFB BIOMEDICAMENTS, 3 avenue des Tropiques, BP 40305, 91958, Courtaboeuf Cedex, France.
    Background: A highly purified 10% liquid intravenous immunoglobulin, IQYMUNE, has been developed using an innovative manufacturing process including an affinity chromatography step for the removal of anti-A and anti-B hemagglutinins.

    Objectives: The pathogen (viruses and prions) clearance efficacy of the manufacturing process and its robustness for critical steps were investigated.

    Methods: The manufacturing process of IQYMUNEincludes two dedicated complementary virus reduction steps: solvent/detergent (S/D) treatment and 20 nm nanofiltration as well as two contributing steps, namely caprylic acid fractionation and anion-exchange chromatography. Read More

    Chronic Myeloid Leukemia: Immunobiology and Novel Immunotherapeutic Approaches.
    BioDrugs 2017 Jun;31(3):143-149
    INSERM CIC 1402, CHU de Poitiers, Poitiers, France.
    Imatinib has revolutionized the treatment and prognosis of chronic myeloid leukemia (CML) with survival rates now approaching those of the age-matched healthy population. To be able to discontinue tyrosine kinase inhibitor (TKI) treatment, it is necessary to develop complementary therapies to target minimal residual disease. Recent findings by a number of investigators in both CML mouse models and CML patients offer evidence that many factors in the leukemic microenvironment can collectively contribute to immune escape, including expansion of myeloid-derived suppressor cells, programmed death-1/programmed death-1 ligand interactions resulting in T-cell impairment, expression of soluble suppressive factors such as soluble CD25, and down-regulation of MHC molecules by CML cells. Read More

    Interleukin-1 Blockade: An Update on Emerging Indications.
    BioDrugs 2017 Jun;31(3):207-221
    Department of Infectious Diseases and Immunity, Jessa Hospital, Stadsomvaat 11, 3500, Hasselt, Belgium.
    Interleukin (IL)-1 is a pro-inflammatory cytokine that induces local and systemic inflammation aimed to eliminate microorganisms and tissue damage. However, an increasing number of clinical conditions have been identified in which IL-1 production is considered inappropriate and IL-1 is part of the disease etiology. In autoinflammatory diseases, gout, Schnitzler's syndrome, and adult-onset Still's disease, high levels of inappropriate IL-1 production have been shown to be a key process in the etiology of the disease. Read More

    Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents.
    BioDrugs 2017 Jun;31(3):223-237
    Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea.
    Background: During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade).

    Objective: The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs.

    Methods: Sera from patients with rheumatoid arthritis and ankylosing spondylitis were analysed using an electrochemiluminescence (ECL) bridging assay or Gyros immunoassay, tagged with Remicade or CT-P13 at screening, weeks 14, 30 and 54, and the end of study visit. Read More

    CT-P10 (Truxima™): A Rituximab Biosimilar.
    BioDrugs 2017 Jun;31(3):275-278
    Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
    CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. 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. CT-P10 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 or FL. Read More

    Improving Antibody-Based Cancer Therapeutics Through Glycan Engineering.
    BioDrugs 2017 Jun;31(3):151-166
    Oxford Glycobiology Institute, Department of Biochemistry, University of Oxford, South Parks Road, Oxford, OX1 3QU, UK.
    Antibody-based therapeutics has emerged as a major tool in cancer treatment. Guided by the superb specificity of the antibody variable domain, it allows the precise targeting of tumour markers. Recently, eliciting cellular effector functions, mediated by the Fc domain, has gained traction as a means by which to generate more potent antibody therapeutics. Read More

    Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.
    BioDrugs 2017 Jun;31(3):175-187
    Biosimilars Development, Amgen Inc., Thousand Oaks, CA, 91320, USA.
    Biosimilars are highly similar versions of approved branded biologics. Unlike generics, they are not exact replicas of reference products. Minor differences between biosimilars and reference products in some aspects are expected; likewise, biosimilar products will differ from each other. Read More

    PCSK9 Inhibitors in Hyperlipidemia: Current Status and Clinical Outlook.
    BioDrugs 2017 Jun;31(3):167-174
    South Australian Health and Medical Research Institute, University of Adelaide, PO Box 11060, Adelaide, SA, 5001, Australia.
    The clinical reality of residual risk despite statin (HMG-CoA reductase inhibitor) therapy and emergence of statin intolerance support the need to develop additional lipid-lowering strategies. Proprotein convertase subtilisin kexin type 9 (PCSK9) has received considerable attention by virtue of genetic and clinical studies that have revealed its pivotal role in the regulation of cholesterol homeostasis. Monoclonal antibodies have been developed targeting PCSK9, which have been demonstrated to produce profound low-density lipoprotein cholesterol (LDL-C) lowering when provided as monotherapy or in combination with statins. Read More

    Biosimilars in the United States: Emerging Issues in Litigation.
    BioDrugs 2017 Jun;31(3):189-205
    United States-China Intellectual Property Institute, New York, USA.
    Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. Read More

    Interleukin-5 Inhibitors for Severe Asthma: Rationale and Future Outlook.
    BioDrugs 2017 Apr;31(2):93-103
    Nuffield Department of Medicine, University of Oxford, NDM Research Building, Old Road Campus, Oxford, OX3 7FZ, UK.
    In this review, we outline the pathophysiology of severe asthma and discuss the role of anti-interleukin (IL)-5 inhibitors for the treatment of asthma. Anti-IL-5 treatments have shown efficacy in reducing the rate of severe asthma attacks in eosinophilic asthma. We review the history of the development of these agents, lessons learnt about severe asthma along the way and key clinical trials supporting efficacy of the three anti-IL-5 treatments that are clinically available or undergoing clinical trials in asthma. Read More

    Impact of Guidance on the Prescription Patterns of G-CSFs for the Prevention of Febrile Neutropenia Following Anticancer Chemotherapy: A Population-Based Utilization Study in the Lazio Region.
    BioDrugs 2017 Apr;31(2):117-124
    Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy.
    Background: Current guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low.

    Objective: Our objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription. Read More

    Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid.
    BioDrugs 2017 Apr;31(2):125-134
    R&D Plasma, Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Str. 235, Vienna, Austria.
    Background: The manufacturing process of a new intravenous immune globulin (IVIG) 10% liquid product incorporates two dedicated pathogen safety steps: solvent/detergent (S/D) treatment and nanofiltration (20 nm). Ion-exchange chromatography (IEC) during protein purification also contributes to pathogen safety. The ability of these three process steps to inactivate/remove viruses and prions was evaluated. Read More

    Adalimumab: A Review in Non-Infectious Non-Anterior Uveitis.
    BioDrugs 2017 Apr;31(2):135-142
    Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
    Adalimumab (Humira) is a tumour necrosis factor (TNF)-α inhibitor available in various countries worldwide, including the USA, Japan and those of the EU, for the treatment of non-infectious intermediate, posterior and panuveitis in adults. It is the first biological agent approved for this indication. In two multinational, phase III studies in adults with active and inactive disease, subcutaneous adalimumab significantly reduced the risk of treatment failure relative to placebo following the tapered withdrawal of corticosteroid therapy. Read More

    Adverse Effects of Collagenase in the Treatment of Dupuytren Disease: A Systematic Review.
    BioDrugs 2017 Apr;31(2):105-115
    University of Granada, Granada, Spain.
    Background: Collagenase clostridium histolyticum (CCH) has proven to be both safe and effective in the treatment of Dupuytren disease (DD). The medium-term outcomes are similar to those achieved with surgery, and most adverse effects are self-limiting and considered to be mild or moderate.

    Objective: Our objective was to conduct a systematic review of the adverse effects of CCH in DD since the release of the drug to evaluate the incidence, severity, classification, and definitions of these effects. Read More

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