1,245 results match your criteria BioDrugs[Journal]


The Role of Anti-PD-1/PD-L1 in the Treatment of Skin Cancer.

BioDrugs 2020 May 23. Epub 2020 May 23.

Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Skin 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00428-9DOI Listing

Correction to: MYL1501D Insulin Glargine: A Review in Diabetes Mellitus.

Authors:
Sheridan M Hoy

BioDrugs 2020 May 12. Epub 2020 May 12.

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

The article MYL1501D Insulin Glargine: A Review in Diabetes Mellitus, written by Sheridan M. Read More

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http://dx.doi.org/10.1007/s40259-020-00426-xDOI Listing

Pseudoprogression and Hyperprogression as New Forms of Response to Immunotherapy.

BioDrugs 2020 May 11. Epub 2020 May 11.

Department of Drug Development and Innovation (D3i), Institut Curie, Saint-Cloud, Paris, France.

Indications of immunotherapy in oncology are continuously expanding, and unconventional types of response have been observed with these new treatments. These include transient progressive disease followed by a partial response, described as pseudoprogression, that raises the question of treatment beyond progression; and rapid disease progression associated with clinical decline, reported as hyperprogression. However, there are currently no consensual definitions of these phenomena and their impact on daily practice remains unclear. Read More

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http://dx.doi.org/10.1007/s40259-020-00425-yDOI Listing

Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies.

BioDrugs 2020 Apr 30. Epub 2020 Apr 30.

CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic of Korea.

Background: At EU marketing authorisation, safety data for CT-P13 (biosimilar infliximab) were limited, particularly in some indications, and uncommon adverse events (AEs) could not be evaluated among relatively small analysis populations.

Objectives: Our objective was to investigate the overall safety profile and incidence rate of AEs of special interest (AESIs), including serious infections and tuberculosis, in CT-P13-treated patients.

Methods: Data were pooled from six observational studies representing authorised indications of CT-P13 (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, adult and paediatric Crohn's disease and ulcerative colitis). Read More

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http://dx.doi.org/10.1007/s40259-020-00421-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7223987PMC

Applying Antibodies Inside Cells: Principles and Recent Advances in Neurobiology, Virology and Oncology.

BioDrugs 2020 Apr 16. Epub 2020 Apr 16.

Technische Universität Braunschweig, Institute of Biochemistry, Biotechnology and Bioinformatics, Brunswick, Germany.

To 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00419-wDOI Listing

The Path Towards a Tailored Clinical Biosimilar Development.

BioDrugs 2020 Jun;34(3):297-306

IGBA, Geneva, Switzerland.

Since 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00422-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211192PMC
June 2020
2.989 Impact Factor

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.

BioDrugs 2020 Jun;34(3):405

Pharmacy Outcomes Research Group, Kaiser Permanente, 1800 Harrison St #1301, Oakland, CA, 94612, USA.

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. Read More

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http://dx.doi.org/10.1007/s40259-020-00423-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211201PMC

The Role of Immune Checkpoint Inhibitors in Colorectal Adenocarcinoma.

BioDrugs 2020 Jun;34(3):349-362

Division of Hematology and Medical Oncology, Mayo Clinic Cancer Center, Mayo Clinic Hospital, 5777 E Mayo Blvd, Phoenix, AZ, 85054, USA.

Over 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 treatment of this disease. Read More

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http://dx.doi.org/10.1007/s40259-020-00420-3DOI Listing

Correction to: In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies.

BioDrugs 2020 Jun;34(3):295

Vaccine and Immunotherapy Center, The Wistar Institute, 3601 Spruce Street, Philadelphia, PA, 19104, USA.

The article In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies, written by Ami Patel, Mamadou A. Bah and David B. Read More

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http://dx.doi.org/10.1007/s40259-020-00424-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211189PMC
June 2020
2.989 Impact Factor

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure.

BioDrugs 2020 Jun;34(3):255-263

Cancer Center, Clinique de Genolier, Vaud, Switzerland.

Febrile 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00411-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211191PMC

MYL1501D Insulin Glargine: A Review in Diabetes Mellitus.

Authors:
Sheridan M Hoy

BioDrugs 2020 Apr;34(2):245-251

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

Subcutaneous 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- and US-sourced reference insulin glargine 100 U/mL, with the bioequivalence of pharmacodynamic and pharmacokinetic parameters between these agents shown in adults with type 1 diabetes. Once-daily MYL1501D insulin glargine demonstrated noninferior glycaemic efficacy to that of once-daily reference insulin glargine 100 U/mL in adults with type 1 or 2 diabetes, with its glycated haemoglobin-lowering benefits maintained over the longer-term (52 weeks) and unaffected by previous insulin exposure. Read More

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http://dx.doi.org/10.1007/s40259-020-00418-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217807PMC

Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis.

BioDrugs 2020 Apr;34(2):235-244

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

Certolizumab 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 psoriasis, 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 ≥ 2 point improvement from baseline (PGA0/1 responder) at week 12 (CIMPACT) or 16 (CIMPASI-1 and -2). Read More

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http://dx.doi.org/10.1007/s40259-020-00416-zDOI Listing

Ongoing Developments and Clinical Progress in Drug-Loaded Red Blood Cell Technologies.

BioDrugs 2020 Jun;34(3):265-272

Department of Biomolecular Sciences, Università degli Studi di Urbino Carlo Bo, 61029, Urbino, PU, Italy.

Engineered 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00415-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211199PMC
June 2020
2.989 Impact Factor

Cell-Free Protein Synthesis: A Promising Option for Future Drug Development.

BioDrugs 2020 Jun;34(3):327-348

Fraunhofer Institute for Cell Therapy and Immunology (IZI), Branch Bioanalytics and Bioprocesses (IZI-BB), Am Mühlenberg 13, 14476, Potsdam, Germany.

Proteins 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. Read More

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http://dx.doi.org/10.1007/s40259-020-00417-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211207PMC

Haematopoietic Stem Cell Transplantation for Multiple Sclerosis: Current Status.

BioDrugs 2020 Jun;34(3):307-325

Department of Brain Sciences, Faculty of Medicine, Imperial College London, Burlington Danes Building, Du Cane Road, Hammersmith Hospital Campus, London, W12 0NN, UK.

Autologous haematopoietic stem cell transplantation (AHSCT) is a treatment option for aggressive forms of multiple sclerosis (MS) that has been derived from haematological indications and repurposed for treatment of refractory autoimmune diseases. In the present review, a search for clinical studies on AHSCT was performed on the PubMed website and ClinicalTrials.gov databases. Read More

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http://dx.doi.org/10.1007/s40259-020-00414-1DOI Listing

In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies.

BioDrugs 2020 Jun;34(3):273-293

Vaccine and Immunotherapy Center, The Wistar Institute, 3601 Spruce Street, Philadelphia, PA, 19104, USA.

Antibody immunotherapy is revolutionizing modern medicine. The field has advanced dramatically over the past 40 years, driven in part by major advances in isolation and manufacturing technologies that have brought these important biologics to the forefront of modern medicine. However, the global uptake of monoclonal antibody (mAb) biologics is impeded by biophysical and biochemical liabilities, production limitations, the need for cold-chain storage and transport, as well as high costs of manufacturing and distribution. Read More

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http://dx.doi.org/10.1007/s40259-020-00412-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211204PMC
June 2020
2.989 Impact Factor

Anti-HIV-1 Antibodies: An Update.

BioDrugs 2020 Apr;34(2):121-132

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Even after more than 30 years since its discovery, there is no cure for HIV-1 infection. Combination antiretroviral therapy (cART) is currently the only HIV-1 infection management option in clinics. Despite its success in suppressing viral replication and converting HIV-1 from a lethal infection to a chronic and manageable disease, cART treatment is life long and long-term use can result in major drawbacks such as high cost, multiple side effects, and an increase in the development of multidrug-resistant escape mutants. Read More

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http://dx.doi.org/10.1007/s40259-020-00413-2DOI Listing

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.

BioDrugs 2020 Jun;34(3):395-404

Pharmacy Outcomes Research Group, Kaiser Permanente, 1800 Harrison St #1301, Oakland, CA, 94612, USA.

Purpose: The aim was to compare outcomes in adult patients with inflammatory bowel disease (IBD) who switched to infliximab-dyyb with those who remained on reference product (RP) infliximab in the United States (US) in a retrospective, propensity score-matched, non-inferiority cohort trial.

Methods: This study was a retrospective, non-inferiority study conducted within a US integrated healthcare system and included adult patients with a confirmed diagnosis of Crohn's disease or ulcerative colitis. A 1:1 propensity score matching was utilized to match patients who switched to infliximab-dyyb during the period April 2016-March 2018 to patients who remained on RP infliximab. Read More

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http://dx.doi.org/10.1007/s40259-020-00409-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211187PMC

Correction to: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.

BioDrugs 2020 04;34(2):253

Institute of Cellular Medicine, Newcastle University and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

The article Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents, written by Vibeke Strand, Joao Gonçalves, Timothy P. Hickling, Heather E. Jones, Lisa Marshall and John D. Read More

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http://dx.doi.org/10.1007/s40259-020-00410-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113198PMC

Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial.

BioDrugs 2020 Jun;34(3):381-393

Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.

Objective: The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.

Methods: A multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. Read More

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http://dx.doi.org/10.1007/s40259-020-00408-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211209PMC
June 2020
2.989 Impact Factor

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology.

BioDrugs 2020 Jun;34(3):363-379

Shanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.

Background: A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes.

Objectives: The aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 and Europe-sourced Herceptin (EU-Herceptin) and China-sourced Herceptin (CN-Herceptin) following a quality-by-design (QbD) quality study and tier-based quality attribute evaluation.

Methods: A panel of highly sensitive and orthogonal methods, including a novel Fc gamma receptor IIIa (FcγRIIIa) affinity chromatography technique that enables quantitative comparison of glycan effects on effector function, was developed for the assessment. Read More

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http://dx.doi.org/10.1007/s40259-020-00407-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211197PMC

Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study.

BioDrugs 2020 Apr;34(2):183-196

Development, Biologics, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland.

Objectives: The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan [RTX-US] and MabThera [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.

Methods: In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC), AUC from day 1 through week 16 (AUC), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC). Read More

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http://dx.doi.org/10.1007/s40259-020-00406-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113224PMC

Targeted Biologic Therapy for Systemic Lupus Erythematosus: Emerging Pathways and Drug Pipeline.

BioDrugs 2020 Apr;34(2):133-147

Department of Rheumatology, "Asklepieion" General Hospital, 1 Vasileos Pavlou Str., Voula, 16673, Athens, Greece.

Following the approval of belimumab, the first drug to be approved for systemic lupus erythematosus (SLE) in over 50 years, advances in our understanding of the pathogenesis of the disease have led to a remarkable number of clinical trials for investigational drugs, each with a unique mechanism of action. These include, but are not limited to, antibodies targeting B or T cells or their interaction, dendritic cells, interferon, and other cytokines. Frustratingly, this boost of studies has not been accompanied by a corresponding success and subsequent approval of novel agents, for reasons only partly attributed to the efficacy of the drugs per se. Read More

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http://dx.doi.org/10.1007/s40259-020-00405-2DOI Listing

Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study.

BioDrugs 2020 Apr;34(2):209-223

Department of Chemical Engineering, Indian Institute of Technology, Delhi, Hauz Khas, New Delhi, 110016, India.

Background: Biotherapeutics are protein products generated using recombinant DNA technology and manufactured in prokaryotic or eukaryotic cells. It is often said that "the process is the product" and thereby the effect of the manufacturing process is etched on the final product in the form of its heterogeneity. For any biotherapeutic, the acceptable range of the critical quality attributes is defined based on the expected impact of a specific variation on the product stability, safety, and efficacy. Read More

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http://dx.doi.org/10.1007/s40259-020-00404-3DOI Listing

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.

BioDrugs 2020 Apr;34(2):197-207

Schlosspark-Klinik University Medicine, Heubnerweg 2, 14059, Berlin, Germany.

Objective: Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study.

Methods: In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). Read More

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http://dx.doi.org/10.1007/s40259-019-00403-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113200PMC
April 2020
2.989 Impact Factor

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

BioDrugs 2020 Apr;34(2):225-233

Biogen International GmbH, Neuhofstrasse 30, 6340, Baar, Switzerland.

Background: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2). Read More

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http://dx.doi.org/10.1007/s40259-019-00402-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113226PMC

Second-Generation C5 Inhibitors for Paroxysmal Nocturnal Hemoglobinuria.

BioDrugs 2020 Apr;34(2):149-158

Department of Haematological Medicine, King's College Hospital, National Institute of Health Research/Wellcome King's Clinical Research Facility, London, SE5 9RS, UK.

The C5 targeting monoclonal antibody eculizumab has changed the natural history of paroxysmal nocturnal hemoglobinuria (PNH) in the last 10 years. However, some unmet clinical needs persist, including persistent anemia with some patients requiring transfusions, incomplete C5 inhibition with breakthrough hemolysis (because of pharmacokinetic or pharmacodynamic issues such as infections, as well as conditions increasing complement activity), the underlying bone marrow failure, and the significant burden on patient quality of life (intravenous route of administration and frequency of infusions). Moreover, a subclass of patients carries C5 polymorphisms resistant to eculizumab inhibition. Read More

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http://dx.doi.org/10.1007/s40259-019-00401-1DOI Listing

Bispecific Antibodies for Autoimmune and Inflammatory Diseases: Clinical Progress to Date.

Authors:
Qi Zhao

BioDrugs 2020 Apr;34(2):111-119

Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Taipa, Macau SPR, China.

In autoimmune diseases, a highly complex network comprising diverse cytokines and their receptors on immune cells drives the inflammatory response. A number of therapeutic antibodies targeting these disease-related molecules have been approved for the treatment of autoimmune diseases. Bispecific antibodies (bsAbs), with binding specificity for two different target molecules, have recently been developed for a range of autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis, and tested in clinical trials. Read More

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http://dx.doi.org/10.1007/s40259-019-00400-2DOI Listing

A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).

BioDrugs 2020 Apr;34(2):171-181

University Hospital Centre Zagreb, Kišpatićeva ul. 12, 10000, Zagreb, Croatia.

Background: Biosimilars are highly similar to the licensed biologic ("reference product"), with no clinically meaningful differences in safety, purity, or potency between the two products.

Objective: This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera; rituximab-EU).

Patients And Methods: Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1 were randomized (1:1) to PF-05280586 or rituximab-EU (375 mg/m intravenously [once weekly for 4 weeks at days 1, 8, 15, and 22]), stratified using the Follicular Lymphoma International Prognostic Index 2 classification. Read More

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http://dx.doi.org/10.1007/s40259-019-00398-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113218PMC

Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

BioDrugs 2020 Apr;34(2):159-170

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Louvain, Belgium.

Biosimilar medicines have shown similarity with the originator biologic and offer a similar clinical outcome generally at a lower cost. This paper identifies benefits of off-patent biologics and biosimilars, and illustrates these benefits with empirical data from Europe. We provide a narrative review of published literature on values and benefits of biosimilars in Europe. Read More

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http://dx.doi.org/10.1007/s40259-019-00395-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113204PMC

Small Interfering RNA Therapeutic Inclisiran: A New Approach to Targeting PCSK9.

BioDrugs 2020 Feb;34(1):1-9

Division of Cardiovascular Medicine, Center for Preventive Cardiology, Wake Forest Baptist Medical Center, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.

Hypercholesterolemia is a leading cause of cardiovascular disease and mortality in men and women throughout the USA and abroad. The development of statins (HMG-CoA reductase inhibitors) to lower plasma atherogenic cholesterol levels and improve cardiovascular outcomes represents one of the greatest contributions to clinical science in the twentieth century, although residual risk remains even among statin-treated patients. Our understanding of lipid metabolism took a giant leap forward in 2003 with the discovery of proprotein convertase subtilsin/kexin type 9 (PCSK9), a low abundance circulating protein with an outsized effect on the regulation of plasma cholesterol levels. Read More

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http://dx.doi.org/10.1007/s40259-019-00399-6DOI Listing
February 2020
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Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study.

BioDrugs 2020 Feb;34(1):99-110

Division of Nephrology, Department of Internal Medicine, Keimyung University School of Medicine, 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Korea.

Background: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs.

Objective: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients.

Methods: The study was performed in 24 centers in Korea between June 2015 and June 2017. Read More

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http://dx.doi.org/10.1007/s40259-019-00396-9DOI Listing
February 2020
2.989 Impact Factor

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry.

BioDrugs 2020 Feb;34(1):89-98

Division of Rheumatology, Seoul Metropolitan Government-Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea.

Objective: The aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry.

Methods: Patients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up. Read More

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http://dx.doi.org/10.1007/s40259-019-00393-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6985057PMC
February 2020
5 Reads

Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.

BioDrugs 2020 Feb;34(1):27-37

Institute of Cellular Medicine, Newcastle University and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

The goal of this narrative review was to summarize immunogenicity data of biosimilars or biosimilar candidates for rheumatic diseases, plaque psoriasis, or inflammatory bowel disease (IBD), available in peer-reviewed publications or regulatory documents. PubMed records and regulatory documents were searched for immunogenicity data of TNFα or CD20 inhibitor biosimilars or biosimilar candidates. Data collected included the proportion of patients positive for anti-drug antibodies (ADAbs), proportion with neutralizing antibodies (nAbs) among ADAb-positive patients, ADAb/nAb assay characteristics, cross-reactivity, and the effects of ADAbs on pharmacokinetics, pharmacodynamics, efficacy, and safety. Read More

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http://dx.doi.org/10.1007/s40259-019-00394-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042210PMC
February 2020

The Therapeutic Potential of Nanobodies.

BioDrugs 2020 Feb;34(1):11-26

Cellular and Molecular Immunology, Vrije Universiteit Brussel, Pleinlaan 2, 1050, Brussels, Belgium.

Today, bio-medical efforts are entering the subcellular level, which is witnessed with the fast-developing fields of nanomedicine, nanodiagnostics and nanotherapy in conjunction with the implementation of nanoparticles for disease prevention, diagnosis, therapy and follow-up. Nanoparticles or nanocontainers offer advantages including high sensitivity, lower toxicity and improved safety-characteristics that are especially valued in the oncology field. Cancer cells develop and proliferate in complex microenvironments leading to heterogeneous diseases, often with a fatal outcome for the patient. Read More

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http://dx.doi.org/10.1007/s40259-019-00392-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6985073PMC
February 2020
2 Reads

Biosimilars: An Opportunity to Update the Product Information of Biological Drugs Regarding their Immunogenicity.

BioDrugs 2019 Dec;33(6):693-695

Faculty of Pharmacy, iMed.ULisboa-Research Institute for Medicines, Universidade de Lisboa, Lisbon, Portugal.

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http://dx.doi.org/10.1007/s40259-019-00391-0DOI Listing
December 2019

Crystal Structures of PF-06438179/GP1111, an Infliximab Biosimilar.

BioDrugs 2020 Feb;34(1):77-87

Analytical Research and Development, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA, 01810, USA.

Background: Higher-order structure (HOS) assessment is an important component of biosimilarity evaluations. While established spectroscopic methods are routinely used to characterize structure and evaluate similarity, the addition of X-ray crystallographic analysis to these biophysical methods enables orthogonal elucidation of HOS at higher resolution.

Methods: Crystal structures of the infliximab biosimilar PF-06438179/GP1111 and the reference product Remicade, sourced from US and European Union markets, were determined and compared to evaluate HOS similarity. Read More

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http://dx.doi.org/10.1007/s40259-019-00390-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6985046PMC
February 2020

Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics.

BioDrugs 2020 Feb;34(1):39-54

Bioagilytix, Lademannbogen 10, 22339, Hamburg, Germany.

Compounds containing two or more structural domains with a distinct mode of action relevant to functionality have been defined as multi-domain biotherapeutics (MDBs). Several modalities, including endogenous protein fusions with an antibody Fc fragment or another polypeptide, bispecific antibodies, antibody-drug conjugates, as well as polyethylene glycol conjugates have been viewed as examples of MDBs. Similar to other biotherapeutics, MDBs have the potential to induce a host immune response, commonly detected in the form of anti-drug antibodies (ADAs). Read More

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http://dx.doi.org/10.1007/s40259-019-00389-8DOI Listing
February 2020

Delivering on the Promise of Biosimilars.

Authors:
Arnold G Vulto

BioDrugs 2019 Dec;33(6):599-602

Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.

Fifteen years of experience with biosimilar evaluation in Europe and advancement in the science behind biological medicines, provides a timely moment to open up debate as to whether the requirements for biosimilar approval could be further tailored. Further optimizing of data requirements to truly decisional information will allow to continuously deliver on the promise of biosimilars, providing benefits for patients and society. Read More

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http://link.springer.com/10.1007/s40259-019-00388-9
Publisher Site
http://dx.doi.org/10.1007/s40259-019-00388-9DOI Listing
December 2019
6 Reads

Author's Reply to Puértolas-Tena and Pérez-Surio: "Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis".

BioDrugs 2019 10;33(5):585-588

Department of Epidemiology and Biostatistics, School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.

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http://dx.doi.org/10.1007/s40259-019-00379-wDOI Listing
October 2019
1 Read
2.989 Impact Factor

Comment on: "Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis".

BioDrugs 2019 Oct;33(5):583-584

Pharmacy Department, University Clinical Hospital Lozano Blesa, Avda. San Juan Bosco 15, 50009, Zaragoza, Aragon, Spain.

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http://dx.doi.org/10.1007/s40259-019-00383-0DOI Listing
October 2019

In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study.

BioDrugs 2020 Feb;34(1):55-64

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.

Background And Objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15-20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009-2015.

Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009-2015. Read More

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http://dx.doi.org/10.1007/s40259-019-00385-yDOI Listing
February 2020
2 Reads

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically.

BioDrugs 2019 Dec;33(6):683-691

iMed.ULisboa-Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.

Objective: The aim of this analysis was to evaluate whether the current unsystematic assessment leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European market.

Methods: Immunogenicity-related information was identified and extracted from a group of 72 biological drugs that complied with drug-selection criteria. Afterwards, 12 dichotomous questions were proposed to evaluate whether any issues are being commonly neglected. Read More

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http://dx.doi.org/10.1007/s40259-019-00387-wDOI Listing
December 2019
9 Reads

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product.

BioDrugs 2020 Feb;34(1):65-75

Chemical Works of Gedeon Richter Plc, Gyömrői út 19-21, Budapest, 1103, Hungary.

Background: In January 2017, the European Commission approved Terrosa (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo (Lilly France S.A.S. Read More

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http://dx.doi.org/10.1007/s40259-019-00386-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6985066PMC
February 2020
1 Read

CAR-T Engineering: Optimizing Signal Transduction and Effector Mechanisms.

BioDrugs 2019 Dec;33(6):647-659

Department of Immunology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.

The adoptive transfer of genetically engineered T cells expressing a chimeric antigen receptor (CAR) has shown remarkable results against B cell malignancies. This immunotherapeutic approach has advanced and expanded rapidly from preclinical models to the recent approval of CAR-T cells to treat lymphomas and leukemia by the Food and Drug Administration (FDA). Ongoing research efforts are focused on employing CAR-T cells as a therapy for other cancers, and enhancing their efficacy and safety by optimizing their design. Read More

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http://dx.doi.org/10.1007/s40259-019-00384-zDOI Listing
December 2019
1 Read

Steady-State Plasma Concentrations of Polyethylene Glycol (PEG) are Reached in Children and Adults During Once-Weekly Prophylactic Treatment with Nonacog Beta Pegol (N9-GP).

BioDrugs 2019 Dec;33(6):673-681

Novo Nordisk A/S, Novo Nordisk Park, 2760, Måløv, Denmark.

Background: Nonacog beta pegol (N9-GP, Refixia, Rebinyn) is a human recombinant coagulation factor IX (rFIX) conjugated to a 40-kDa polyethylene glycol (PEG) moiety. PEGylation significantly prolongs the circulation half-life compared with conventional FIX replacement treatments, resulting in higher FIX levels. Although there is extensive clinical experience with PEGylated molecules, the potential for abnormal and/or indefinite PEG accumulation during long-term treatment and the hypothetical impact on long-term safety is still under discussion. Read More

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http://dx.doi.org/10.1007/s40259-019-00380-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875145PMC
December 2019
2 Reads

Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar.

BioDrugs 2019 Dec;33(6):661-671

Quality Evaluation Team, Samsung Bioepis Co., Ltd, 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

Background: SB3, a biosimilar of Herceptin (trastuzumab, hereinafter referred to as reference product) is currently approved in the EU, Korea, Australia, the USA, and Brazil for the treatment of human epidermal growth factor receptor (HER) 2-positive early and metastatic breast cancer and HER2-positive metastatic gastric cancer. Previously, the biological similarity of SB3 to EU- or US-sourced reference product was assessed using various cell-based and binding assays.

Objective: In this paper, as a part of its similarity assessment, SB3 was evaluated for additional characteristics related to its molecular mechanism of action (MoA). Read More

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http://dx.doi.org/10.1007/s40259-019-00381-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875161PMC
December 2019
3 Reads

Correction to: Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta‑Analysis.

BioDrugs 2019 10;33(5):589-594

Department of Epidemiology and Biostatistics, School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.

The authors unintentionally included in the meta-analysis both the initial abstract and the final paper of the study by Puertolas et al. [45, 48]. In order to remove this duplication, the following corrections are required. Read More

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http://dx.doi.org/10.1007/s40259-019-00378-xDOI Listing
October 2019
2 Reads
2.989 Impact Factor

Evolution of the EU Biosimilar Framework: Past and Future.

BioDrugs 2019 Dec;33(6):621-634

Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.

The approval of biosimilars in the EU follows a comprehensive scientific assessment based on stringent regulatory standards. While the initial approach to biosimilars was understandably cautious and conservative in that uncharted territory to protect patients' safety, the analytical and scientific progress and accumulated experience with biosimilars continues to reshape regulatory requirements, generally leading to a reduced burden of clinical trials. This trend is expected to continue, for example, by increasingly employing pharmacodynamic endpoints and biomarkers, but much work remains to make this happen, especially for complex molecules with several or unknown mechanisms of action. Read More

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http://dx.doi.org/10.1007/s40259-019-00377-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875146PMC
December 2019

Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies.

BioDrugs 2019 Oct;33(5):571-579

Clinical Pharmacology, Global Product Development, Pfizer Inc, Groton, CT, USA.

Background: Anti-drug antibodies (ADAs) to bococizumab were detected in > 40% of subjects in the SPIRE lipid-lowering trials. The risk of cross-reactivity between anti-bococizumab antibodies and other approved anti-proprotein convertase subtilisin/kexin type-9 (PCSK9) monoclonal antibodies (mAbs) was investigated using a single-assay approach.

Methods: Bococizumab immunogenicity was assessed in SPIRE-HR, a 52-week study. Read More

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http://dx.doi.org/10.1007/s40259-019-00375-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790354PMC
October 2019
1 Read