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Biotechnology Products Research

04:07 EST 23rd January 2019 | BioPortfolio

Patients' information and perspectives on biosimilars in rheumatology: a French nation-wide survey.

To assess the patients' information about biosimilars and to identify the patients' incentives and deterrents to concur with the use of biosimilars.

Pharmacokinetics, excretion, distribution, and metabolism of 60-kDa polyethylene glycol used in BAY 94-9027 in rats and its value for human prediction.

The covalent binding of proteins with polyethylene glycol (PEG) molecules is a valuable tool to extend the half-life of many biotherapeutics, including factor VIII (FVIII) products to treat patients with haemophilia A. Although PEG has low toxicity, accumulation of large PEG molecules (>20-30 kDa) with long-term exposure is a potential concern. Thus, it is important to determine whether sufficie...

Analysis of the immunoglobulin G (IgG) secretion efficiency in recombinant Chinese hamster ovary (CHO) cells by using Citrine-fusion IgG.

Biopharmaceuticals represented by immunoglobulin G (IgG) are produced by the cultivation of recombinant animal cells, especially Chinese hamster ovary (CHO) cells. It is thought that the intracellular secretion process of IgG is a bottleneck in the production of biopharmaceuticals. Many studies on the regulation of endogenous secretory protein expression levels have shown improved productivity. Ho...

Clinical experience with the etanercept biosimilar SB4 in psoriatic patients.

Background After the expiry of the patent of reference etanercept, several biosimilars have been developed, including SB4. Objective To study safety and efficacy of SB4 in psoriatic patients previously treated with etanercept and in the etanercept naive ones. Method Patients affected by moderate to severe psoriasis and/or psoriatic arthritis attending the Psoriasis Center of Florence University, t...

The future landscape of biosimilars in rheumatology: Where we are where we are going.

The upcoming of biosimilars in rheumatic diseases have generated considerable interest throughout the past five years among pharmaceutical industries and regulatory agencies, their development is associated with considerable variation and heterogeneity on the variable requirements for license and marketing throughout the various continents.

Customized protein glycosylation to improve biopharmaceutical function and targeting.

For a long time, glycoprotein production has been limited by the inherent properties of production hosts. Glycosylation of biopharmaceuticals has been regarded as a necessary evil, often needed for protein folding or function, but also a source of heterogeneity, complicating downstream processing and product characterization. This has strongly determined the choice of production hosts. Over the la...

Biosimilars: Are They Really Safe?

An increasing availability of biosimilars is an important step in the process of delivering optimal care while improving access for patients with cancer. Evolving regulatory mechanisms deal with biosimilars with different approaches within major regulatory agencies. We discuss some of the specific properties of biosimilars that merit attention in terms of optimizing their safety, delivering on app...

Use and costs of originator and biosimilar erythropoiesis-stimulating agents in the treatment of chemotherapy-induced anemia: real-world evidence from an Italian hospital.

The aim of this retrospective study is to evaluate adherence, switch and costs a year after the start of treatment with different erythropoietin-stimulating agents. There were 277 patients, 200 were originators (72.20%) and 77 (27.80%) were biosimilars. Adherence to treatment for originators is 0.84 ± 0.22 versus 0.76 ± 0.27 for biosimilars (p = 0.3241). Medication adherence was calculated...

Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition.

Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,...

Spray drying of pharmaceuticals and biopharmaceuticals: Critical parameters and experimental process optimization approaches.

Spray drying is increasingly becoming recognized as an efficient drying and formulation technique for pharmaceutical and biopharmaceutical processing. It offers significant economic and processing advantages compared to lyophilisation/freeze-drying techniques even though the optimisation of process parameters is often a costly and time-consuming procedure. Spray Drying has primarily been used in f...

Acknowledgement to Referees.

The US Biosimilar Market: Stunted Growth and Possible Reforms.

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the Food and Drug Administration had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulat...

Validation of an ADCC assay using human primary natural killer cells to evaluate biotherapeutic products bearing an Fc region.

The development of biotherapeutics requires continuous improvement in analytical methodologies for the assessment of their quality attributes. A subset of biotherapeutics is designed to interact with specific antigens that are exposed on the membranes of target cells or circulating in a soluble form, and effector functions are achieved via recognition of their Fc region by effector cells that indu...

Codelivery of a cytotoxin and photosensitiser via a liposomal nanocarrier: a novel strategy for light-triggered cytosolic release.

Endosomal entrapment is a key issue for the intracellular delivery of many nano-sized biotherapeutics to their cytosolic or nuclear targets. Photochemical internalisation (PCI) is a novel light-based solution that can be used to trigger the endosomal escape of a range of bioactive agents into the cytosol leading to improved efficacy in pre-clinical and clinical studies. PCI typically depends upon ...

Immunoglobulin E as a Biomarker in Asthma.

Asthma is a chronic disease that affects children and adults with significant morbidity and mortality. It is multifactorial, with genetic and environmental factors affecting the overall course of the disease. Both specific and total immunoglobulin (Ig)E can be used in specific phenotypes such as allergic asthma. Using IgE as a biomarker for asthma provides a target for management and treatment. Bi...

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.

In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example,...

Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.

Although anti-tumor necrosis factor (TNF) agents have greatly improved the management of rheumatic diseases, their cost limits access to many patients throughout the world. As a result, patients and clinicians have turned to biosimilars to provide similar efficacy at a lower cost. Many of the regulatory guidelines in the Asia Pacific region are largely based on those of the European Medicines Agen...

Biosimilar Agents for Psoriasis Treatment: The Perspective of Portuguese Patients.

Biosimilars are highly similar copies of previously approved original biologic medicines. Their introduction on the market may yield cost reduction. The aim of this study was to evaluate the perspectives of psoriasis patients on biosimilar medications.

Cross-Interaction Chromatography as a Rapid Screening Technique to Identify the Stability of New Antibody Therapeutics.

Protein aggregation can be a major problem in the manufacturing of new biopharmaceuticals and there is a desirability for development of techniques that can predict the behaviour of new biopharmaceuticals early on in the development process. A technique that can be used to predict aggregation is self-interaction chromatography that is used to determine the second virial coefficient, B, but one of ...

How similar is biosimilar? A comparison of Infliximab therapeutics in regard to charge variant profile and antigen binding affinity.

Biosimilars are increasing in economic importance. Just how similar a biosimilar needs to be to gain market approval is currently still decided on a per case basis. We try to shed light on one often cited critical quality attribute of monoclonal antibodies, namely charge heterogeneity. Using high resolution electrophoretic and chromatographic methods, we are able to separate and quantify the charg...

Report on the Second PANLAR Review Course in Rheumatology: Biosimilars Update.

Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent.

The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less ...

Biosimilar medicines used for cancer therapy in Europe: a review.

This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bev...

The host cell proteome of Physcomitrella patens harbours proteases and protease inhibitors under bioproduction conditions.

Host cell proteins are inevitable contaminants of biopharmaceuticals. Here, we performed detailed analyses of the host cell proteome of moss (Physcomitrella patens) bioreactor supernatants using mass spectrometry and subsequent bioinformatics analysis. Distinguishing between the apparent secretome and intracellular contaminants, a complex extracellular proteolytic network including subtilisin-like...

Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars.

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate that the pharmacokinetic (PK) and clinical efficacy are equivalent. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated...

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