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Biotechnology Products Research

08:04 EST 22nd November 2017 | BioPortfolio

Biosimilars in oncology: much ado about nothing?

Biosimilars Forum Applauds Food and Drug Administration on New Educational Program Promoting Safety and Effectiveness of Biosimilars.

Can we transfer the mechanisms of the generics market to biosimilars?

Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the ex...

The importance of biosimilars medicines for private and statutory health insurance.

Patented biopharmaceuticals generate huge costs for private and statutory health insurance. Exactly ten years ago, off-patent biopharmaceuticals, also referred to as 'biosimilars medicines', became available as a more cost-efficient and therapeutically equivalent alternative in Germany and Europe. Following their approval by all the relevant authorities, biosimilars medicines can therefore be appl...

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

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

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

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

Financial costs associated with monopolies on biologic medicines in Australia.

Objectives The aim of the study was to estimate the potential savings to the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) in 2015-16 if biosimilar versions of selected biologic medicines (biologics) had been available and listed on the PBS.Methods The research involved retrospective analysis of Australian Medicare expenditure data and PBS price da...

Development of a robust reporter gene based assay for the bioactivity determination of IL-5-targeted therapeutic antibodies.

Eosinophilic asthma is characterized by the eosinophilic inflammation with the allergen independent activation of Th2 lymphocytes. Since IL-5 plays an important role in the maturation, survival and migration of eosinophils, hence the pathogenesis of eosinophilic asthma, biotherapeutics targeting IL-5/IL-5Rα have been developed and/or marketed, including Mepolizumab, Reslizumab, and Benralizumab. ...

Protein Turnover Measurements in Human Serum by Serial Immunoaffinity LC-MS/MS.

The half-life of target proteins is frequently an important parameter in mechanistic pharmacokinetic and pharmacodynamic (PK/PD) modeling of biotherapeutics. Clinical studies for accurate measurement of physiologically relevant protein turnover can reduce the uncertainty in PK/PD model-based predictions, for example, of the therapeutic dose and dosing regimen in first-in-human clinical trials.

Two-Dimensional Isoelectric Focusing OFFGEL, Micro-fluidic Lab-on-Chip Electrophoresis and FTIR for assessment of long-term stability of rhG-CSF formulation.

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) has been increasingly recognized from among one of the most abundant families of biosimilars. Upon long-term storage, rhG-CSF is subject to subtle chemical modifications that rapidly occur and, in particular, produce deaminated variants with divergent charge. Indeed, changes in charge from glutamine deamination may alter the way rhG...

Understanding State Regulation of Biosimilars and Effect on Prescribers.

Biologics are a mainstay of treatment for many dermatologic conditions, however the high costs can be prohibitive for many patients. A growing market of biosimilar drugs is emerging with the hope of providing patients access to more affordable medications. While the FDA has created an abbreviated licensure pathway for these drugs, states are still in the process of creating regulations regarding t...

The Supreme Court's interpretation of the biosimilars statute and the value of certainty.

IgG Fc engineering to modulate antibody effector functions.

Therapeutic monoclonal antibodies are among the most effective biotherapeutics to date. An important aspect of antibodies is their ability to bind antigen while at the same time recruit immune effector functions. The majority of approved recombinant monoclonal antibody therapies are of the human IgG1 subclass, which can engage both humoral and cellular components of the immune system. The wealth o...

The expanding therapeutic armamentarium for inflammatory bowel disease: how to choose the right drug(s) for our patients?

The therapeutic landscape for inflammatory bowel disease (IBD) is rapidly evolving. Two new biologic drugs, vedolizumab and ustekinumab, have recently entered the marketplace, the first biosimilars have been introduced, and several other agents are at an advanced stage of clinical development. In parallel, therapeutic goals have shifted from symptom control towards mucosal healing and prevention o...

A comprehensive screening platform for aerosolizable protein formulations for intranasal and pulmonary drug delivery.

Aerosolized administration of biopharmaceuticals to the airways is a promising route for nasal and pulmonary drug delivery, but - in contrast to small molecules - little is known about the effects of aerosolization on safety and efficacy of biopharmaceuticals. Proteins are sensitive against aerosolization-associated shear stress. Tailored formulations can shield proteins and enhance permeation, bu...

Therapeutic miRNA and siRNA: Moving from Bench to Clinic as Next Generation Medicine.

In the past few years, therapeutic microRNA (miRNA) and small interfering RNA (siRNA) are some of the most important biopharmaceuticals that are in commercial space as future medicines. This review summarizes the patents of miRNA- and siRNA-based new drugs, and also provides a snapshot about significant biopharmaceutical companies that are investing for the therapeutic development of miRNA and siR...

Science of Biosimilars.

Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilar...

Biosimilars: Reimbursement Issues in Your Oncology Practice.

Emerging Opportunities and Challenges of Biosimilars in Oncology Practice.

Biosimilars: Implications for Clinical Practice.

In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The p...

European Perspective on Biosimilars.

Optimization of Capillary Zone Electrophoresis for Charge Heterogeneity testing of Biopharmaceuticals using Enhanced Method Development Principles.

Capillary zone electrophoresis is a well-established technique for charge heterogeneity testing of biopharmaceuticals 1. It is based on the differences between the ratios of net charge and hydrodynamic radius. In an extensive intercompany study, it was recently shown that capillary zone electrophoresis is very robust and can be easily implemented in labs that did not perform it before 2. However, ...

Peptide dendrons as thermal stability amplifiers for IgG1 monoclonal antibody biotherapeutics.

Biotherapeutics such as monoclonal antibodies (mAbs) have a major share of the pharmaceutical industry for treatment of life-threatening chronic diseases such as cancer, skin ailments and immune disorders. Instabilities such as aggregation, fragmentation, oxidation and reduction have resulted in the practice of storing these products at low temperatures (-80ºC to -20ºC). However, reliable storag...

To engraft or not to engraft: an ecological framework for gut microbiome modulation with live microbes.

Strategies aimed at modulating the gut microbiota by using live microbes range from single strains (probiotics or live biotherapeutics) to whole non-defined fecal transplants. Although often clinically efficacious, our understanding on how microbial-based strategies modulate gut microbiome composition and function is vastly incomplete. In this review, we present a framework based on ecological the...

Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.

The study aimed to develop evidence-based recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases. The task force comprised an expert group of specialists in rheumatology, dermatology and gastroenterology, and pharmacologists, patients and a regulator from ten countries. Four key topics regarding biosimilars were identified through a process of discussion ...

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