Designer Exosomes: A New Platform for Biotechnology Therapeutics
AbstractDesirable features of exosomes have made them a suitable manipulative platform for biomedical applications, including targeted drug delivery, gene therapy, cancer diagnosis and therapy, development of vaccines, and tissue regeneration. Although natural exosomes have various potentials, their clinical application is associated with some inherent limitations. Recently, these limitations inspired various attempts to engineer exosomes and develop designer exosomes. Mostly, designer exosomes are being developed to overcome the natural limitations of exosomes for targeted delivery of drugs and functional molecules to wou...
Source: BioDrugs - August 4, 2020 Category: Drugs & Pharmacology Source Type: research

Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score –Matched Analysis from the Korean College of Rheumatology Biologics Registry
ConclusionsPropensity score –matching analysis confirmed that CT-P13 treatment was not associated with significant differences in drug retention, treatment duration, most efficacy parameters, or safety versus reference infliximab in Korean patients with ankylosing spondylitis, building evidence for the long-term comparabilit y of these treatments.Trial registrationClinicalTrials.gov identifier: NCT01965132. (Source: BioDrugs)
Source: BioDrugs - July 21, 2020 Category: Drugs & Pharmacology Source Type: research

The Importance of Countering Biosimilar Disparagement and Misinformation
AbstractBiosimilar use is limited in some healthcare systems because biosimilars are not well understood by many healthcare professionals and patients. The knowledge gap is exacerbated by disparagement of biosimilars and dissemination of misinformation, whether intentional or otherwise. There are several different types of disparagement and misinformation directed towards biosimilars as a class, including statements about biosimilar science or policy that are factually incorrect; misleading information, where the information is correct, but is provided out of context; incomplete information, where only partial or a limited...
Source: BioDrugs - July 20, 2020 Category: Drugs & Pharmacology Source Type: research

Update on Biosimilar Insulins: A US Perspective
AbstractThe development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar® (insulin glargine) and Admelog® (insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the op...
Source: BioDrugs - July 17, 2020 Category: Drugs & Pharmacology Source Type: research

Beyond Antibodies: The DARPin ® Drug Platform
AbstractThe DARPin® drug platform was established with a vision to expand the medical use of biologics beyond what was possible with monoclonal antibodies. It is based on naturally occurring ankyrin repeat domains that are typically building blocks of multifunctional human proteins. The platform allows for the generation of diverse, well-behaved, multifunctional drug candidates. Recent clinical data illustrate the favorable safety profile of the first DARPin® molecules tested in patients. With the positive phase III results of the most advanced DARPin® drug candidate, abicipar, the DARPin® drug platform is ...
Source: BioDrugs - June 24, 2020 Category: Drugs & Pharmacology Source Type: research

Potential Role of Anti-interleukin (IL)-6 Drugs in the Treatment of COVID-19: Rationale, Clinical Evidence and Risks
AbstractThe epidemic due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. This public health emergency has triggered a race to find medications to improve the prognosis of this disease. There is currently great interest in drug repositioning to manage SARS-CoV-2 infection, that is, the evaluation of the potential benefits of a drug that has already been proven safe and effective in humans for other approved indications. As interleukin-6 (IL-6) acts as a key driver of the inflammation associated with coronavirus disease 2019 (COVID-19), IL-6 ...
Source: BioDrugs - June 15, 2020 Category: Drugs & Pharmacology Source Type: research

Targeted Therapies for Eosinophilic Gastrointestinal Disorders
AbstractThe growing recognition of eosinophilic gastrointestinal disorders has revealed the limitations of current treatment (mainly based on dietary modification and corticosteroids), and include refractoriness, high recurrence rates, and the need for long-term therapy. Research efforts, mainly in eosinophilic esophagitis (EoE), have unveiled essential pathophysiological mechanisms leading to these disorders, which bear some similarities to those of atopic manifestations and are shared by eosinophilic gastroenteritis (EGE) and eosinophilic colitis (EC). Novel targeted therapies, some imported from bronchial asthma and ato...
Source: BioDrugs - May 29, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Anti-PD-1/PD-L1 in the Treatment of Skin Cancer
AbstractSkin cancers remain the most common group of cancers globally, and the incidence continues to rise. Although localized skin cancers tend to have excellent outcomes following surgical excisions, the less common cases that become surgically unresectable or metastatic have been associated with poor prognosis and suboptimal treatment responses to cytotoxic chemotherapy. Development of monoclonal antibodies to programmed cell death-1 receptor and its ligand (PD-1/PD-L1) have transformed the management of metastatic melanoma, squamous cell carcinoma, and Merkel cell carcinoma. These agents, as monotherapies, are associat...
Source: BioDrugs - May 23, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
The article MYL1501D Insulin Glargine: A Review in Diabetes Mellitus, written by Sheridan M. (Source: BioDrugs)
Source: BioDrugs - May 12, 2020 Category: Drugs & Pharmacology Source Type: research

Pseudoprogression and Hyperprogression as New Forms of Response to Immunotherapy
In conclusion, pseudoprogression and hyperprogression are both frequent types of responses under immunotherapy, and there is a need to better characterize these to improve the management of cancer patients. Treatment beyond progression should always be considered with caution and necessitates close clinical monitoring. In case of suspected hyperprogression, immunotherapy should be stopped early. (Source: BioDrugs)
Source: BioDrugs - May 11, 2020 Category: Drugs & Pharmacology Source Type: research

Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies
ConclusionThe CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment. (Source: BioDrugs)
Source: BioDrugs - April 30, 2020 Category: Drugs & Pharmacology Source Type: research

Applying Antibodies Inside Cells: Principles and Recent Advances in Neurobiology, Virology and Oncology
AbstractTo interfere with cell function, many scientists rely on methods that target DNA or RNA due to the ease with which they can be applied. Proteins are usually the final executors of function but are targeted only indirectly by these methods. Recent advances in targeted degradation of proteins based on proteolysis-targeting chimaeras (PROTACs), ubiquibodies, deGradFP (degrade Green Fluorescent Protein) and other approaches have demonstrated the potential of interfering directly at the protein level for research and therapy. Proteins can be targeted directly and very specifically by antibodies, but using antibodies ins...
Source: BioDrugs - April 16, 2020 Category: Drugs & Pharmacology Source Type: research

The Path Towards a Tailored Clinical Biosimilar Development
AbstractSince the first approval of a biosimilar medicinal product in 2006, scientific understanding of the features and development of biosimilar medicines has accumulated. This review scrutinizes public information on development programs and the contribution of the clinical studies for biosimilar approval in the European Union (EU) and/or the United States (US) until November 2019. The retrospective evaluation of the programs that eventually obtained marketing authorization and/or licensure revealed that in 95% (36 out of 38) of all programs, the comparative clinical efficacy studies confirmed similarity. In the remaini...
Source: BioDrugs - April 7, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
The article Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study, written by Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning and Rita L. Hui, was originally published electronically on 26 February 2020 without open access. (Source: BioDrugs)
Source: BioDrugs - April 6, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Immune Checkpoint Inhibitors in Colorectal Adenocarcinoma
AbstractOver the past decade, immune checkpoint inhibitors (ICI) have proven to be promising agents in a number of solid tumor malignancies. Pembrolizumab and nivolumab are ICIs that target programmed cell death protein  1 and both have been approved by the US Food and Drug Administration for the treatment of microsatellite instability-high/DNA mismatch repair deficient (MSI-H/dMMR) colorectal cancer (CRC). In MSI-H/dMMR CRC, these agents were found to have considerable antitumor activity and are now used in the t reatment of this disease. However, MSI-H/dMMR tumors account for only 5% of metastatic CRC and the remain...
Source: BioDrugs - April 3, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies
The article In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies, written by Ami Patel, Mamadou A. Bah and David B. (Source: BioDrugs)
Source: BioDrugs - April 2, 2020 Category: Drugs & Pharmacology Source Type: research

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure
AbstractFebrile neutropenia (FN) is a serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions and, ultimately, reduce cancer survival. Over the past decade, the availability of biosimilar filgrastim (short-acting granulocyte colony-stimulating factor [G-CSF]) has transformed patient access, with clear evidence of clinical benefit at preventing FN at reduced costs. In 2019, seven biosimilar pegfilgrastims (long-acting G-CSFs) were licensed, creating optimal market conditions and choice for prescribers. FN affects up to 117 per 1000 cancer patients, with...
Source: BioDrugs - March 30, 2020 Category: Drugs & Pharmacology Source Type: research

MYL1501D Insulin Glargine: A Review in Diabetes Mellitus
AbstractSubcutaneous MYL1501D insulin glargine 100  U/mL (hereafter referred to as MYL1501D insulin glargine) [Semglee®] is a long-acting human insulin analogue approved as a biosimilar of insulin glargine 100  U/mL (hereafter referred to as reference insulin glargine 100 U/mL) [Lantus®] in various countries, including those of the EU for the treatment of diabetes mellitus in patients aged  ≥ 2 years, as well as Japan for diabetes where insulin therapy is indicated. MYL1501D insulin glargine has similar physicochemical characteristics and biological properties to those of EU- an...
Source: BioDrugs - March 25, 2020 Category: Drugs & Pharmacology Source Type: research

Certolizumab Pegol: A Review in Moderate to Severe Plaque Psoriasis
AbstractCertolizumab pegol (Cimzia®) is a PEGylated, Fab ′-only, recombinant humanized antibody against TNF-α. Subcutaneous certolizumab pegol is indicated for the treatment of various immune-mediated inflammatory diseases (IMIDs), including moderate to severe plaque psoriasis. In pivotal phase III trials in adults with moderate to severe plaque psoria sis, significantly more patients receiving certolizumab pegol 200 mg or 400 mg once every 2 weeks than placebo recipients achieved a ≥ 75% reduction in PASI score (PASI75 responder) and a PGA score of clear/mostly clear with a&...
Source: BioDrugs - March 23, 2020 Category: Drugs & Pharmacology Source Type: research

Ongoing Developments and Clinical Progress in Drug-Loaded Red Blood Cell Technologies
AbstractEngineered red blood cells (RBCs) appear to be a promising method for therapeutic drug and protein delivery. With a number of agents in clinical trials (e.g., dexamethasone 21-phosphate in ataxia telangiectasia, asparaginase in pancreatic cancer/acute lymphoblastic leukemia, thymidine phosphorylase in mitochondrial neurogastrointestinal encephalomyopathy, RTX-134 in phenylketonuria, etc.), this leading article summarizes the ongoing efforts in developing these agents, focuses on the clinical progress, and provides a brief background into engineered RBCs and the different ways in which they can be exploited for ther...
Source: BioDrugs - March 20, 2020 Category: Drugs & Pharmacology Source Type: research

Cell-Free Protein Synthesis: A Promising Option for Future Drug Development
AbstractProteins are the main source of drug targets and some of them possess therapeutic potential themselves. Among them, membrane proteins constitute approximately 50% of the major drug targets. In the drug discovery pipeline, rapid methods for producing different classes of proteins in a simple manner with high quality are important for structural and functional analysis. Cell-free systems are emerging as an attractive alternative for the production of proteins due to their flexible nature without any cell membrane constraints. In a bioproduction context, open systems based on cell lysates derived from different source...
Source: BioDrugs - March 20, 2020 Category: Drugs & Pharmacology Source Type: research

Haematopoietic Stem Cell Transplantation for Multiple Sclerosis: Current Status
AbstractAutologous 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. Papers were selected according to the following criteria: text written in English language, publication date between 2014 and August 2019, and reports including more than five patients. Prospective randomised and uncontrolled trials and retro...
Source: BioDrugs - March 12, 2020 Category: Drugs & Pharmacology Source Type: research

In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies
AbstractAntibody 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 l imitations, the need for cold-chain storage and transport, as well as high costs of manufacturing and distribution. Some of these hurdles may be overcome through transient in vivo gene delivery platforms, ...
Source: BioDrugs - March 10, 2020 Category: Drugs & Pharmacology Source Type: research

Anti-HIV-1 Antibodies: An Update
AbstractEven 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 manageab le 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. Recently, antibody-based anti-HIV-1 treatment has emerged as a potential alternative ther...
Source: BioDrugs - March 9, 2020 Category: Drugs & Pharmacology Source Type: research

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
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. The non-inferiority margin was set at + 10% of the upper limit. The primary outcome was a composite measure of disease worsening requiring acute care after the index date of switching to infliximab-dyyb or continuing RP infliximab. Disea...
Source: BioDrugs - February 26, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents
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 Gon çalves, Timothy P. Hickling, Heather E. Jones, Lisa Marshall and John D. Isaacs, was originally published Online First without Open Access. (Source: BioDrugs)
Source: BioDrugs - February 26, 2020 Category: Drugs & Pharmacology Source Type: research

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
ConclusionHS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.Trial registration numberChiCTR1900022520. (Source: BioDrugs)
Source: BioDrugs - February 20, 2020 Category: Drugs & Pharmacology Source Type: research

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin ® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology
ConclusionBesides having an overall high analytical similarity to both EU-Herceptin® and CN-Herceptin®, HLX02 is more similar to Herceptin® with high Fc γRIIIa affinity, a result that demonstrates the power of the novel FcγRIIIa affinity chromatography technology in biosimilarity evaluation. (Source: BioDrugs)
Source: BioDrugs - February 18, 2020 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Na ïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study
ConclusionDRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.Clinical Trials Registration NumberClinicalTrials.gov identifier: NCT02296775. (Source: BioDrugs)
Source: BioDrugs - February 12, 2020 Category: Drugs & Pharmacology Source Type: research

Targeted Biologic Therapy for Systemic Lupus Erythematosus: Emerging Pathways and Drug Pipeline
AbstractFollowing 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 cel ls, 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 attribute...
Source: BioDrugs - January 30, 2020 Category: Drugs & Pharmacology Source Type: research

Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study
ConclusionsOverall, the results indicated general similarity with respect to structure and function, but we found variations with respect to size heterogeneity, charge heterogeneity, and glycosylation pattern in each of the biosimilars. (Source: BioDrugs)
Source: BioDrugs - January 23, 2020 Category: Drugs & Pharmacology Source Type: research

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
ConclusionsResults to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54.Trial Registration NumberNCT02222493. (Source: BioDrugs)
Source: BioDrugs - January 14, 2020 Category: Drugs & Pharmacology Source Type: research

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars
ConclusionsQuality attributes of SB4 and SB2 batches showed little variation and were consistently within the rigorous specifications defined by regulatory agencies. (Source: BioDrugs)
Source: BioDrugs - January 10, 2020 Category: Drugs & Pharmacology Source Type: research

Bispecific Antibodies for Autoimmune and Inflammatory Diseases: Clinical Progress to Date
AbstractIn 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. This review briefly describes the three main categories of bsAb structure...
Source: BioDrugs - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Second-Generation C5 Inhibitors for Paroxysmal Nocturnal Hemoglobinuria
AbstractThe 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 activ ity), the underlying bone marrow failure, and the significant burden on patient quality of life (intravenous route of administration and frequency of infusions). Moreover, a sub...
Source: BioDrugs - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

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)
ConclusionsThe efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU were similar up to week 52 in subjects with previously untreated CD20-positive LTB-FL.Clinical Trial RegistrationClinicalTrials.gov, NCT02213263 and EudraCT (2014-000132-41). (Source: BioDrugs)
Source: BioDrugs - December 9, 2019 Category: Drugs & Pharmacology Source Type: research

Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!
AbstractBiosimilar 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. The results describe cost savings as the key driver stemming from the lower price of biosimilars, than that of originator products, and from price competition between biosimilar(s), originator, and next-generation products. Cost savings may then t...
Source: BioDrugs - December 2, 2019 Category: Drugs & Pharmacology Source Type: research

Small Interfering RNA Therapeutic Inclisiran: A New Approach to Targeting PCSK9
AbstractHypercholesterolemia 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 ...
Source: BioDrugs - November 28, 2019 Category: Drugs & Pharmacology Source Type: research

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
ConclusionThe changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis. (Source: BioDrugs)
Source: BioDrugs - November 20, 2019 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: BioDrugs)
Source: BioDrugs - November 19, 2019 Category: Drugs & Pharmacology Source Type: research

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry
ConclusionLong-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile.ClinicalTrials.gov identifierNCT01965132. (Source: BioDrugs)
Source: BioDrugs - November 16, 2019 Category: Drugs & Pharmacology Source Type: research

Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents
In conclusion, immunogenicity data of biosimilars or biosimilar candidates for TNFα or CD20 inh ibitors were collected in trials that varied in design and procedures for ADAb/nAb detection. In general, immunogenicity parameters of biosimilars are similar to those of their reference products. (Source: BioDrugs)
Source: BioDrugs - November 13, 2019 Category: Drugs & Pharmacology Source Type: research

The Therapeutic Potential of Nanobodies
AbstractToday, 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. Although antibo...
Source: BioDrugs - November 4, 2019 Category: Drugs & Pharmacology Source Type: research

Biosimilars: An Opportunity to Update the Product Information of Biological Drugs Regarding their Immunogenicity
(Source: BioDrugs)
Source: BioDrugs - October 25, 2019 Category: Drugs & Pharmacology Source Type: research

Crystal Structures of PF-06438179/GP1111, an Infliximab Biosimilar
ConclusionThe structures provide new insights into the physicochemical properties of the proposed biosimilar and the reference product, further strengthening  the ‘totality of evidence’ in the evaluation of similarity. (Source: BioDrugs)
Source: BioDrugs - October 24, 2019 Category: Drugs & Pharmacology Source Type: research

Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics
AbstractCompounds 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). The need to characterize ADA specificity to a particula...
Source: BioDrugs - October 22, 2019 Category: Drugs & Pharmacology Source Type: research

Delivering on the Promise of Biosimilars
AbstractFifteen 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. (Source: BioDrugs)
Source: BioDrugs - October 12, 2019 Category: Drugs & Pharmacology Source Type: research

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”
(Source: BioDrugs)
Source: BioDrugs - October 9, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on: “Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis”
(Source: BioDrugs)
Source: BioDrugs - October 9, 2019 Category: Drugs & Pharmacology Source Type: research

In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study
ConclusionsSwitching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch. (Source: BioDrugs)
Source: BioDrugs - October 8, 2019 Category: Drugs & Pharmacology Source Type: research