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Biotechnology Products Research

10:00 EDT 27th May 2017 | BioPortfolio

Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review.

The production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein- and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoi...

A 'Global Reference' Comparator for Biosimilar Development.

Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multipli...

Biosimilars Ready, At Last, To Make Their Entrance: Stars Are Born or Do They Fizzle?

The future of biosimilars in this country is nothing if not uncertain. Most immediately, the U.S. Supreme Court is hearing a case that will determine the timing of the 180-day waiting period before a biosimilar can go on the market. But there are larger and longer-term issues at play as well.

The Biosimilar Pipeline Seams Seem To Be Bursting.

The biosimilar segment of the pharmaceutical industry is on fire. Some 700 biosimilars are at some stage of development, and more than 660 companies are involved in some way in the biosimilars land rush. Still, only a handful may get on the market in the next few years.

Biosimilars in Oncology: Reality Could Bite the Copycats, Dog Potential Major Savings.

No one knows how much of an effect biosimilars will have on oncology expenditures. Pricing and market share are in a large, opaque "to be determined" cloud. But there's certainly potential for a major impact that could lower oncology expenditures by millions, if not billions.

Managed Care Reader Poll: Readers Believe Biosimilars Will Be Effective Against Costs.

In an online survey of readers conducted in late January and early February, 20% of the 113 respondents indicated that they believed that biosimilars will be highly effective in lowering drug costs, and the reader ratings of their effectiveness skewed toward positive.

New Solutions for Curbing Runaway Drug Costs.

Long at odds, the interests of payers and providers are becoming more compatible and aligned. Both stakeholders need to collaborate to manage costs. Encouraging use of generics and biosimilars is one way they can slow down the soaring drug spend.

Rationale for therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases.

Biopharmaceuticals bring together a number of specific characteristics as compared with other drugs. However, as done for most drugs, an individual adjustment of their dose may be necessary. Similar to "chemical" drugs, biopharmaceuticals used in immuno-inflammatory diseases have a rather narrow therapeutic range, lack good early clinical or biological marker of response, have variable pharmacokin...

Clinical development of biologicals and biosimilars - safety concerns.

Obstacles to the Adoption of Biosimilars for Chronic Diseases.

Retention of glycopeptides analyzed using hydrophilic interaction chromatography is influenced by charge and carbon chain length of ion-pairing reagent for mobile phase.

Characterization of the glycans of glycoproteins is essential for the development and production of biologics. Numerous methods are available for analyzing the glycans of glycoproteins directly and labeled glycans. Nevertheless, glycopeptides are difficult to resolve because of their exceptional complexity and the microheterogeneity of glycans. These properties represent technical challenges to ef...

Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany.

This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars.

Analytic characterization of biosimilars.

The biosimilar development process, comparability for biological agents, and analytic characterization of biosimilars are described.

Biosimilars in Rheumatologie: a New Challenge?

TILT Biotherapeutics.

Current practice of therapeutic drug monitoring of biopharmaceuticals in psoriasis patients.

The high prevalence of psoriasis and the high spending on pharmaceuticals motivate a more evidence-based and cost-effective usage of biopharmaceuticals. A growing body of evidence exists that the implementation of therapeutic drug monitoring (TDM) for biopharmaceuticals in psoriasis patients optimizes patient management and clinical outcome and enhances their efficacy. Therefore, the aim of this r...

Current practice of therapeutic drug monitoring of biopharmaceuticals in spondyloarthritis.

Treatment of spondyloarthritis (SpA) has greatly improved in the biopharmaceutical era. These compounds, primarily tumor necrosis factor (TNF) inhibitors, are effective, but some patients may show poor response, sometimes due to the presence of anti-drug antibodies (ADAs). In some instances, clinicians may increase or taper the dose, depending on the clinical response. Besides the current clinical...

Trastuzumab and Pertuzumab Plant Biosimilars: Modification of Asn297-linked Glycan of the mAbs Produced in a Plant with Fucosyltransferase and Xylosyltransferase Gene Knockouts.

Plant biosimilars of anticancer therapeutic antibodies are of interest not only because of the prospects of their practical use, but also as an instrument and object for study of plant protein glycosylation. In this work, we first designed a pertuzumab plant biosimilar (PPB) and investigated the composition of its Asn297-linked glycan in comparison with trastuzumab plant biosimilar (TPB). Both bio...

Comparability study of Rituximab originator and follow-on biopharmaceutical.

Immunglobolin G (IgG)-based biopharmaceuticals are emerging on the pharmaceuticals market due to their high target selectivity in different diseases. In parallel, a growing interest by other companies to produce similar or highly similar follow-on biologics exits, once the patent of blockbuster biotherapeutics is about to expire. In correlation to their complex structure, an analytical challenge i...

Interleukin-5 Inhibitors for Severe Asthma: Rationale and Future Outlook.

In this review, we outline the pathophysiology of severe asthma and discuss the role of anti-interleukin (IL)-5 inhibitors for the treatment of asthma. Anti-IL-5 treatments have shown efficacy in reducing the rate of severe asthma attacks in eosinophilic asthma. We review the history of the development of these agents, lessons learnt about severe asthma along the way and key clinical trials suppor...

Accuracy Considerations in Sterile Compounding.

Published information about the accuracy of filling and closing operations of sterile products is limited and guidelines on the topic are very general. This article highlights the basic principles in sterile-product filling of syringes and vials. Also covered in this article are descriptions of some of the available devices for filling containers, a brief discussion of the advances in vial and syr...

Current practice for therapeutic drug monitoring of biopharmaceuticals in inflammatory bowel disease.

Since the late nineties, biopharmaceuticals targeting tumor necrosis factor α have revolutionized the treatment of moderately to severely active inflammatory bowel disease. The robust efficacy witnessed in many patients stands in stark contrast with the observation of a proportion of patients who fail to respond or who lose response over time. Therapeutic drug monitoring has been proposed as a me...

Drug Efficacy Monitoring in Pharmacotherapy of Multiple Sclerosis with Biological Agents.

Multiple Sclerosis (MS) is a heterogeneous disease. Although several EMA approved Disease Modifying Treatments including biopharmaceuticals are available, their efficacy is limited and a certain percentage of patients are always non-responsive. Drug Efficacy Monitoring is an important tool to identify these non-responsive patients early on. Currently, Detection of Anti-Drug Antibodies and quantifi...

The Path of Interchangeability of Biosimilars in Pediatric Inflammatory Bowel Disease: Quality Before Cost-Savings.

The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, co...

Biosimilars in psoriasis: the future or not?

As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed "highly similar" to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimil...

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