Comparative Efficacy and Safety of Biosimilar Rituximab and Originator Rituximab in Rheumatoid Arthritis and Non-Hodgkin ’s Lymphoma: A Systematic Review and Meta-analysis
ConclusionThis systematic review and conventional meta-analysis demonstrated the overall similarity of the long-term efficacy and safety of biosimilar rituximab to those of originator rituximab in RA and NHL patients by combining direct evidence from head-to-head trials.PROSPERO registration No. CRD42019125138. (Source: BioDrugs)
Source: BioDrugs - August 24, 2019 Category: Drugs & Pharmacology Source Type: research

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim
AbstractBiosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the “totality of evidence” concept, an approach that considers data from structural and functional characterization and comparability analysis and non-clinical and clinical studies. For biosimilar filgrastim, phase III confirmatory clinical studies were performed in the most sensitive population, pa tients with breast cancer undergoing myelosuppressive chemotherapy. In Europe and the USA, approval was granted for all indications of the reference bio...
Source: BioDrugs - August 22, 2019 Category: Drugs & Pharmacology Source Type: research

Mission Possible: Advances in MYC Therapeutic Targeting in Cancer
AbstractMYC is a master transcriptional regulator that controls almost all cellular processes. Over the last several decades, researchers have strived to define the context-dependent transcriptional gene programs that are controlled by MYC, as well as the mechanisms that regulate MYC function, in an effort to better understand the contribution of this oncoprotein to cancer progression. There are a wealth of data indicating that deregulation of MYC activity occurs in a large number of cancers and significantly contributes to disease progression, metastatic potential, and therapeutic resistance. Although the therapeutic targ...
Source: BioDrugs - August 7, 2019 Category: Drugs & Pharmacology Source Type: research

Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
AbstractThe status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians. (Source: BioDrugs)
Source: BioDrugs - August 6, 2019 Category: Drugs & Pharmacology Source Type: research

An Efficient Development Paradigm for Biosimilars
AbstractThe current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in some jurisdictions), and clinical studies (including powered efficacy studies in most cases); this paradigm is known as ‘totality of evidence’ (ToE) and does not admit a conclusion of biosimilarity from analytical data alone. The record of biosimilar approvals in these jurisdictions shows that no biosimilar can...
Source: BioDrugs - August 6, 2019 Category: Drugs & Pharmacology Source Type: research

The Expanding Class 2 CRISPR Toolbox: Diversity, Applicability, and Targeting Drawbacks
AbstractThe class 2 clustered regularly interspaced short palindromic repeats (CRISPR)-Cas system, one of the prokaryotic adaptive immune systems, has sparked a lot of attention for its use as a gene editing tool. Currently, type II, V, and VI effector modules of this class have been characterized and extensively tested for nucleic acid editing, imaging, and disease diagnostics. Due to the unique composition of their nuclease catalytic center, the effector modules substantially vary in their function and possible biotechnology applications. In this review, we discuss the structural and functional diversity in class 2 CRISP...
Source: BioDrugs - August 5, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”
(Source: BioDrugs)
Source: BioDrugs - August 1, 2019 Category: Drugs & Pharmacology Source Type: research

Chimeric Antigen Receptor-T Cells for Targeting Solid Tumors: Current Challenges and Existing Strategies
AbstractChimeric antigen receptor-T  cells (CAR-Ts) are an exciting new cancer treatment modality exemplified by the recent regulatory approval of two CD19-targeted CAR-T therapies for certain B cell malignancies. However, this success in the hematological setting has yet to translate to a significant level of objective clinical res ponses in the solid tumor setting. The reason for this lack of translation undoubtedly lies in the substantial challenges raised by solid tumors to all therapies, including CAR-T, that differ from B cell malignancies. For instance, intravenously infused CAR-Ts are likely to make ...
Source: BioDrugs - July 30, 2019 Category: Drugs & Pharmacology Source Type: research

PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin ® ), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study
ConclusionAmong patients with advanced non-squamous NSCLC, PF-06439535 demonstrated similarity to bevacizumab-EU in terms of efficacy. Safety profiles for the two treatments were comparable.Trial RegistrationClinicalTrials.gov, NCT02364999.FundingPfizer. (Source: BioDrugs)
Source: BioDrugs - July 23, 2019 Category: Drugs & Pharmacology Source Type: research

Oncolytic Viruses: Priming Time for Cancer Immunotherapy
AbstractNew immuno-oncology therapies are improving cancer treatments beyond the former standard of care, as evidenced by the recent and continuing clinical approvals for immunotherapies in a broad range of indications. However, a majority of patients (particularly those with immunologically cold tumors) still do not benefit, highlighting the need for rational combination approaches. Oncolytic viruses (OV) both directly kill tumor cells and inflame the tumor microenvironment. While OV spread can be limited by the generation of antiviral immune responses, the initial local tumor cell killing can reverse the immunosuppressiv...
Source: BioDrugs - July 18, 2019 Category: Drugs & Pharmacology Source Type: research

Challenges in Post-marketing Studies of Biological Drugs in the Era of Biosimilars: A Report of the International Society for Pharmacoepidemiology 2019 Mid-Year Meeting in Rome, Italy
AbstractSeveral controversial issues related to challenges in the post-marketing studies of biological drugs, including biosimilars, were discussed at the International Society for Pharmacoepidemiology (ISPE) 2019 Mid-Year Meeting in Rome (Italy) in April. In recent years, the marketing of biosimilars has been growing, thus offering opportunities for wider access by patients to high-cost biological drugs as well as ensuring the economic sustainability of national healthcare systems. Through the comparability exercise required for marketing approval, the similarity of biosimilars to the reference products in terms of effica...
Source: BioDrugs - July 16, 2019 Category: Drugs & Pharmacology Source Type: research

Hematopoietic Stem Cell Transplantation for Systemic Sclerosis: Review of Current Status
AbstractThree prospective controlled clinical trials and numerous small series and case reports have confirmed that durable, drug-free remission in systemic sclerosis is possible via an autologous hematopoietic stem cell transplantation. Similar results have been seen in other autoimmune diseases. The exact mechanism by which this immune “reset” was achieved in some but not all cases remains elusive, but includes major reduction of autoreactive immune competent cells, re-establishment of T- and B cell regulatory networks and normalization of tissue niche function, particularly vascular. Some aspects regarding m...
Source: BioDrugs - July 13, 2019 Category: Drugs & Pharmacology Source Type: research

Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine
AbstractMonoclonal antibody (mAb) therapies have revolutionized the treatment of several chronic inflammatory diseases, including the inflammatory bowel diseases (IBD), Crohn ’s disease, and ulcerative colitis. While efficacious, responses to these therapies vary considerably from patient to patient, due in part to inter- and intra-individual variability in pharmacokinetics (PK) and drug exposure. The concept of personalized medicine to monitor drug exposure and to adj ust dosing in individual patients is consequently gaining acceptance as a powerful tool to optimize mAb therapy for improved outcomes in IBD. This rev...
Source: BioDrugs - July 12, 2019 Category: Drugs & Pharmacology Source Type: research

Budget Impact of Switching to Biosimilar Trastuzumab (CT-P6) for the Treatment of Breast Cancer and Gastric Cancer in 28 European Countries
ConclusionsThe conducted budget impact analysis assessing a switch from originator trastuzumab to biosimilar CT-P6 in 28 European countries indicates that budget savings could be between €0.91 billion and €2.27 billion over the next 5 years. These savings could be used to help improve patient access to local biologics in their respective countries while simultaneously strengthening the overall public health landscape across the European Union. (Source: BioDrugs)
Source: BioDrugs - June 14, 2019 Category: Drugs & Pharmacology Source Type: research

Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment
ConclusionSB3 has been developed as a trastuzumab biosimilar approved in the EU and USA, and its manufacturing process is deemed to be robust and well-controlled within stringent quality target ranges. (Source: BioDrugs)
Source: BioDrugs - June 12, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Anti-cancer Biosimilars Compared to Reference Biologics in Oncology: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
ConclusionThe existing evidence suggests highly comparable efficacy and safety profiles between mAb biosimilars and their reference biologics in oncological drugs. (Source: BioDrugs)
Source: BioDrugs - June 7, 2019 Category: Drugs & Pharmacology Source Type: research

Biosimilars: A Value Proposition
AbstractBiosimilars are biological agents that effectively replicate original reference products. The main driver of their development is the promise of bringing competition into the marketplace, and consequently contributing to the sustainability of healthcare systems. By reducing financial barriers to biological therapies, biosimilars play a part in budgetary redistribution and, hence, in increasing patients ’ access to treatment. They also foster innovation and deliver other non-price-driven advantages. However, the market is such that harmonization of pricing of reference biologics and biosimilars may dissuade ph...
Source: BioDrugs - June 7, 2019 Category: Drugs & Pharmacology Source Type: research

Bimekizumab: The First Dual Inhibitor of Interleukin (IL)-17A and IL-17F for the Treatment of Psoriatic Disease and Ankylosing Spondylitis
AbstractPsoriasis is a chronic inflammatory skin disease with significant psychological and physical impact. Over the last few decades, several highly effective target therapies have been developed, leading to a major paradigm shift in the way psoriatic disease is managed. Despite this, a proportion of patients still do not respond or lose response over time. Bispecific antibodies target two different cytokines simultaneously, potentially offering a better disease control. Interleukin (IL)-17A and IL-17F share structural homology and have similar biologic function. IL-17A is classically considered to be the most biological...
Source: BioDrugs - June 6, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis
ConclusionExisting evidence suggests highly comparable efficacy and safety profiles for supportive care biosimilars and their reference biologics in oncology. (Source: BioDrugs)
Source: BioDrugs - June 3, 2019 Category: Drugs & Pharmacology Source Type: research

Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence
AbstractAdalimumab, the first fully humanised monoclonal antibody against tumour necrosis factor alpha (TNF- α), has played a leading role in the revolution brought about by the introduction of biologics, and has received the widest range of indications among TNF-α inhibitors. Post-registration, observational and registry studies of real-life use have largely supported the outcomes seen in registrational clinical trials. With the recent loss of exclusivity for the originator medicinal product in Europe, a number of biosimilar adalimumab molecules have been licensed for use in the same indications as the origina...
Source: BioDrugs - May 20, 2019 Category: Drugs & Pharmacology Source Type: research

Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
ConclusionOur analysis reveals that, in most cases, the reference biological products originated from the EU and those from the USA are almost indistinguishable in terms of PK/PD properties. Additional in vivo bridging studies between reference products from different global regions may not be required if similar physicochemical and structural properties are evident in vitro. (Source: BioDrugs)
Source: BioDrugs - May 20, 2019 Category: Drugs & Pharmacology Source Type: research

Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics
AbstractChimeric antigen receptor (CAR) T-cell immunotherapy has gained significant attention in the past decade due to its considerable potential in the treatment of various types of malignancies, particularly hematological. While success has been achieved in a number of studies, and two CAR-T-cell products were recently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) (YESCARTA®, KYMRIAH®), this treatment modality continues to present challenges for clinical development. One major potential side effect is the ability of CAR-T products to induce host immune responses. I...
Source: BioDrugs - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin ® ) in Healthy Male Subjects
ConclusionIn this study, BAT1706, a proposed biosimilar of BEV, was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence, safety, and immunogenicity in healthy subjects  after a single IV infusion.Trial RegistrationNCT03030430. (Source: BioDrugs)
Source: BioDrugs - April 23, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Vestronidase Alfa: A Review in Mucopolysaccharidosis VII
The article Vestronidase Alfa: A Review in Mucopolysaccharidosis VII, written by Emma H. McCafferty and Lesley J. Scott, was originally published Online First without open access. (Source: BioDrugs)
Source: BioDrugs - April 16, 2019 Category: Drugs & Pharmacology Source Type: research

Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab
ConclusionBased on the comprehensive analytical similarity assessment, ABP 980 is analytically highly similar to the reference product, trastuzumab. (Source: BioDrugs)
Source: BioDrugs - April 10, 2019 Category: Drugs & Pharmacology Source Type: research

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2 —Biosimilar and Originator Etanercept in the Outpatient Setting
ConclusionsRegional variations in use of biosimilar etanercept can be seen although prices are coordinated nationally. This suggests that counties react differently to price differences and highlights the role of local policy and attitudes of stakeholders towards biosimilars and switching. It seems that some counties are hesitant to switch patients, as it is associated with an increased administrative workload that might not be compensated for by savings associated with a lower priced product. (Source: BioDrugs)
Source: BioDrugs - April 3, 2019 Category: Drugs & Pharmacology Source Type: research

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1 —Biosimilar and Originator Infliximab in the Hospital Setting
ConclusionsVariations in the market share of biosimilar infliximab between the Swedish counties is largely explained by the discounted price difference between biosimilar and originator product, and counties used different strategies to leverage such biosimilar competition. Additionally, the presence of key opinion leaders, local guidelines and gainsharing arrangements appeared to play a role in infliximab market dynamics in counties. (Source: BioDrugs)
Source: BioDrugs - April 3, 2019 Category: Drugs & Pharmacology Source Type: research

Physicochemical and Biological Characterization of RTXM83, a New Rituximab Biosimilar
ConclusionRTXM83 is similar to its reference product in all critical quality attributes. (Source: BioDrugs)
Source: BioDrugs - March 29, 2019 Category: Drugs & Pharmacology Source Type: research

PF-06881893 (Nivestym ™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen ® ): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers
ConclusionsNivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.Trial registrationClinicalTrials.gov C1121002 (NCT02766647); C1121003 (NCT02766634); C1121012 (NCT02923791). (Source: BioDrugs)
Source: BioDrugs - March 21, 2019 Category: Drugs & Pharmacology Source Type: research

PARP Inhibitors and the Evolving Landscape of Ovarian Cancer Management: A Review
AbstractAs a drug class, inhibitors of poly-(ADP-ribose) polymerase (PARP) have had their greatest impact on the treatment of women with epithelial ovarian cancers (EOC), in particular, those with the most common histological subtype, high-grade serous cancer, as it has high rates of homologous recombination (HR) deficiency. PARP inhibition exploits this cancer vulnerability by further disrupting DNA repair, thus leading to genomic catastrophe. Early clinical data demonstrated the effectiveness of PARP inhibition in women with recurrent EOC harbouringBRCA1/2 mutations and those with platinum-sensitive recurrences. Three PA...
Source: BioDrugs - March 21, 2019 Category: Drugs & Pharmacology Source Type: research

LA-EP2006: A Pegfilgrastim Biosimilar
AbstractLA-EP2006 (Ziextenzo®) is the fifth biosimilar of pegfilgrastim, a pegylated recombinant granulocyte colony-stimulating factor, to be approved in the EU. It is approved for use in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) to reduce the duration of neutropenia and the incidence of febrile neutropenia. LA-EP2006 matched reference pegfilgrastim in terms of physicochemical characteristics and functional properties, and the pharmacodynamic and pharmacokinetic similarity of the medicines has been shown in healthy volunteer...
Source: BioDrugs - March 18, 2019 Category: Drugs & Pharmacology Source Type: research

Comparative Stability Studies of Different Infliximab and Biosimilar CT-P13 Clinical Solutions by Combined Use of Physicochemical Analytical Techniques and Enzyme-Linked Immunosorbent Assay (ELISA)
ConclusionsHigh levels of similarity were noticed in the behavior of INF and CT-P13 when subjected to stress. When stored refrigerated at between 2 and 8  °C and prepared as normally used in the hospital pharmacy, all solutions showed physicochemical and functional stability for all the concentrations tested and all containers, at least for the 14-day test period. (Source: BioDrugs)
Source: BioDrugs - March 14, 2019 Category: Drugs & Pharmacology Source Type: research

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males
ConclusionCT-P16 demonstrated pharmacokinetic equivalence to EU-bevacizumab and US-bevacizumab. Safety and immunogenicity profiles were similar for CT-P16, EU-bevacizumab, and US-bevacizumab. These data support the further clinical evaluation of CT-P16 as a bevacizumab biosimilar.Clinical Trials RegistrationNCT03247673. (Source: BioDrugs)
Source: BioDrugs - March 9, 2019 Category: Drugs & Pharmacology Source Type: research

Vestronidase Alfa: A Review in Mucopolysaccharidosis VII
AbstractMucopolysaccharidosis VII is an extremely rare, autosomal recessive lysosomal storage disorder characterized by a deficiency of β-glucuronidase activity, resulting in partial degradation and accumulation of GAGs in numerous tissues throughout the body, with consequent cellular damage and organ dysfunction. Enzyme replacement therapy (ERT) with intravenous vestronidase alfa (Mepsevii™), a recombinant form of human β-glucu ronidase, is the first disease-specific therapy approved for the treatment of mucopolysaccharidosis VII in pediatric and adult patients. In the pivotal, blind start, phase 3 trial, ...
Source: BioDrugs - March 8, 2019 Category: Drugs & Pharmacology Source Type: research

CDK4/6 Inhibitors Expand the Therapeutic Options in Breast Cancer: Palbociclib, Ribociclib and Abemaciclib
AbstractThe majority of patients with metastatic breast cancer (MBC) have hormone receptor-positive HER2-negative disease. For this subgroup, endocrine therapy is the key therapeutic option. Recently, therapeutic options have been expanded by introduction of the inhibitors of cyclin-dependent kinases 4/6 (CDK4/6i). Three compounds, palbociclib, ribociclib, and abemaciclib, have already been approved by the FDA for use together with endocrine therapy such as aromatase inhibitors (AIs) or fulvestrant; abemaciclib is also approved as a single agent. In the first-line setting, all three agents —together with an AI—...
Source: BioDrugs - March 7, 2019 Category: Drugs & Pharmacology Source Type: research

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals
ConclusionDue to the numerous concerns relating to the usage of biosimilars, their introduction into patient therapy requires special attention from healthcare providers. While pharmacists involved in the distribution of biosimilars are conscious of their impact in decreasing costs of therapy, they do not feel comfortable in recommending their substitution without a physician ’s permission. There is a need for more precise legal regulations relating to biosimilars, improved communication between physicians and pharmacists, as well as educational initiatives to improve the safe and effective usage of biosimilars. (Source: BioDrugs)
Source: BioDrugs - March 4, 2019 Category: Drugs & Pharmacology Source Type: research

First-Line Treatment of Non-Small-Cell Lung Cancer (NSCLC) with Immune  Checkpoint Inhibitors
AbstractTreatment of advanced-stage or metastatic non-small-cell lung cancers (NSCLCs) withoutEGFR mutations orALK rearrangements, which can now be treated with molecularly targeted therapies, had been based on cytotoxic chemotherapy for a long time. Immune  checkpoint inhibitors (ICIs), notably antibodies directed against programmed cell-death protein-1 (PD-1) and its ligand (PD-L1) have transformed therapeutic standards in thoracic oncology. These ICIs are now the reference second-line treatment and numerous phase III trials have examined their effi cacy in treatment-naïve patients. First-line pembrolizumab mon...
Source: BioDrugs - March 2, 2019 Category: Drugs & Pharmacology Source Type: research

The Relationship between Exosomes and Cancer: Implications for Diagnostics and Therapeutics
AbstractExosomes are very small extracellular vesicles secreted by cells to local and distant tissues. These mini signal transporters elicit acute and chronic effects on recipient cells. Studies regarding exosomes and their relationship to disease, as well as healthy functions, are eliciting extraordinary excitement as data pours in from groups around the world. Reporting of exosome biogenesis, selective loading of cargo, directed release, and resulting changes in adjacent and distal cells are providing information that is changing the way we view cancer progression and treatment. As a result, the properties of exosomes ar...
Source: BioDrugs - February 27, 2019 Category: Drugs & Pharmacology Source Type: research

In-Use Stability of the Rituximab Biosimilar CT-P10 (Truxima ® ) Following Preparation for Intravenous Infusion and Storage
ConclusionsWe demonstrated that CT-P10 was stable after refrigerated storage for up to 6 weeks followed by incubation at room temperature. (Source: BioDrugs)
Source: BioDrugs - February 11, 2019 Category: Drugs & Pharmacology Source Type: research

Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial
ConclusionCT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48.ClinicalTrials.gov identifierNCT02149121. (Source: BioDrugs)
Source: BioDrugs - February 5, 2019 Category: Drugs & Pharmacology Source Type: research

FKB327: An Adalimumab Biosimilar
AbstractFKB327 (Hulio®) is a biosimilar of the reference monoclonal anti-TNF α antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to -severe rheumatoid arthritis (RA) despite methotrexate therapy. FKB327 demonstrated equivalent clinical efficacy to that of reference adalimumab in patients with moderate-to-severe RA, and similar tolerability, safety and immunogenicity profil...
Source: BioDrugs - February 2, 2019 Category: Drugs & Pharmacology Source Type: research

Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar
AbstractPegfilgrastim-jmdb/MYL-1401H (FULPHILA ™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neu tropenia, in the USA and to reduce the duration of neutropenia and the incidence of febrile neutropenia in the EU. Pegfilgrastim-jmdb has similar physicochemical characteristics and functional properties to those of US- and EU-sourced reference pegfilgrastim, and the pharmacody...
Source: BioDrugs - January 30, 2019 Category: Drugs & Pharmacology Source Type: research

Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases
AbstractCytokines, many of which signal through the JAK –STAT (Janus kinase–Signal Transducers and Activators of Transcription) pathway, play a central role in the pathogenesis of inflammatory and autoimmune diseases. Currently three JAK inhibitors have been approved for clinical use in USA and/or Europe: tofacitinib for rheumatoid arthritis, psoriat ic arthritis and ulcerative colitis, baricitinib for rheumatoid arthritis, and ruxolitinib for myeloproliferative neoplasms. The clinical JAK inhibitors target multiple JAKs at high potency and current research has focused on more selective JAK inhibitors, almost a...
Source: BioDrugs - January 30, 2019 Category: Drugs & Pharmacology Source Type: research

Monoclonal Antibodies for Multiple Sclerosis: An Update
AbstractThe use of monoclonal antibodies in multiple sclerosis (MS) patients is in a transitional period. Studies regarding well-established, effective antibodies such as natalizumab and alemtuzumab focus more and more on long-term efficacy and safety, risk management, and treating complications. Primary progressive MS, a disease that was long considered to be unmodifiable, is currently in focus following ocrelizumab being approved as the first drug with a proven beneficial effect on the disease course. Conversely, post-marketing safety mechanisms have also proven to function as daclizumab has been suspended after a series...
Source: BioDrugs - January 2, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on “The End of Phase 3 Clinical Trials in Biosimilars Development?”
(Source: BioDrugs)
Source: BioDrugs - January 2, 2019 Category: Drugs & Pharmacology Source Type: research

Current Ebola Virus Vaccine Progress
AbstractOver 40  years since the discovery of Ebola virus, the anti-Ebola virus vaccine efforts of the past 2 decades have culminated in over 12 different vaccine candidates that have been placed into a number of clinical trial phases, past and present. Of these 12 vaccines, four candidates are up to or in phase I I clinical trials, and only one has completed the phase III clinical trial stage. While remarkable progress toward a national regulatory agency-approved vaccine for Ebola virus has been made, there remain unanswered questions on issues such as, but not limited to, vaccine protective immunity and dur ation of...
Source: BioDrugs - January 2, 2019 Category: Drugs & Pharmacology Source Type: research

The Impact of the Fecal Microbiome on Cancer Immunotherapy
AbstractRecent advances in culture-free methods of studying the human microbiome, coupled with strong bioinformatics tools, have provided new insights on the role of the human microbiome in health and disease. The human gut, in particular, houses a vast number and diverse variety of microbes. A plethora of evidence has demonstrated the significant effects of the gut microbiome on local and systemic immunity. Studies in hematopoietic stem cell transplantation recipients provided early evidence of the involvement of the gut microbiome in the development of graft-versus-host disease and its related mortality. Cancer immunothe...
Source: BioDrugs - January 2, 2019 Category: Drugs & Pharmacology Source Type: research

Mechanisms and Management of Chimeric Antigen Receptor T-Cell Therapy-Related Toxicities
AbstractChimeric antigen receptor T-cell (CAR-T) therapy has proven to be a very effective cancer immunotherapy. Axicabtagene ciloleucel and tisagenlecleucel are the first-in-class anti-CD19 CAR-T currently available for relapsed/refractory adult large B-cell lymphoma. Tisagenlecleucel is also available for pediatric and young adult (up to age 25  years) patients with relapsed/refractory B-acute lymphoblastic leukemia. Cytokine release syndrome (CRS) and CAR-T-associated encephalopathy syndrome (neurotoxicity) are the most common adverse effects associated with CAR-T therapy. They can lead to significant morbidity and...
Source: BioDrugs - December 17, 2018 Category: Drugs & Pharmacology Source Type: research

Lanadelumab for the Prophylactic Treatment of Hereditary Angioedema with C1 Inhibitor Deficiency: A Review of Preclinical and Phase I Studies
AbstractHereditary angioedema (HAE) with C1 esterase inhibitor (C1-INH) deficiency (C1-INH-HAE) is a rare disease characterized by diminished levels or dysfunctional activity of C1-INH, leading to dysregulated plasma kallikrein activity within the kallikrein –kinin pathway. Symptoms manifest as painful, potentially life-threatening swelling of subcutaneous tissues throughout the body and/or submucosal edema in the upper airway or gastrointestinal tract. Attacks recur with unpredictable frequency, intensity, and duration, placing a heavy burden on pati ents’ daily lives. Despite improved availability of medicati...
Source: BioDrugs - December 12, 2018 Category: Drugs & Pharmacology Source Type: research

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects
ConclusionsThis study demonstrated high PK similarity between GB242 and its marketed reference infliximab in healthy subjects. Both treatments showed comparable safety and immunogenicity.Registration numberChiCTR-IPR-15007098 (Source: BioDrugs)
Source: BioDrugs - December 3, 2018 Category: Drugs & Pharmacology Source Type: research