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Biotechnology Products Research

06:53 EDT 28th July 2017 | BioPortfolio

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points.

Today, the assessment of immunogenicity is integral in nonclinical and clinical testing of new biotherapeutics and biosimilars. A key component in the risk-based evaluation of immunogenicity involves the detection and characterization of anti-drug antibodies (ADA). Over the past couple of decades, much progress has been made in standardizing the generalized approach for ADA testing with a three-ti...

Biosimilars in Oncology in the United States: A Review.

Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for...

Biosimilars: biologics that meet patients' needs and healthcare economics.

Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same i...

How to select a nanosimilar.

Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but clinical differences have been observed. Many healthcare professionals may be unaware of this issue and ...

Current Practice for Therapeutic Drug Monitoring of Biopharmaceuticals in Rheumatoid Arthritis.

The treatment of rheumatoid arthritis (RA) has largely improved in the biopharmaceutical era. These compounds, primarily tumor necrosis factor (TNF) inhibitors, are effective, but some patients may show poor response, sometimes because of the presence of antidrug antibodies (ADAs). In some instances, clinicians may increase or taper the dose depending on the clinical response. Besides the current ...

The use of biosimilars in paediatric inflammatory bowel disease.

After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience...

Plant glyco-biotechnology.

Glycosylation is an important protein modification in all eukaryotes. Whereas the early asparagine-linked glycosylation (N-glycosylation) and N-glycan processing steps in the endoplasmic reticulum are conserved between mammals and plants, the maturation of complex N-glycans in the Golgi apparatus differs considerably. Due to a restricted number of Golgi-resident N-glycan processing enzymes and the...

A Survey Assessment of US Dermatologists' Perception of Biosimilars.

BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications. OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists. METHODS: An online survey was sent to ...

Biosimilars-Curb Your Enthusiasm.

Correlation between Dynamic Light Scattering and Size Exclusion High Performance Liquid Chromatography for Monitoring the Effect of pH on Stability of Biopharmaceuticals.

Aggregate formation is a major problem affecting both safety and efficacy of biopharmaceuticals and is associated with protein immunogenicity. Size exclusion high performance liquid chromatography (SE-HPLC) has always been the gold standard technique for detection and determination of protein aggregates. However, large protein aggregates may be filtered off and build up on top of the column leadin...

Immunoassays for measuring serum concentrations of monoclonal antibodies and anti-biopharmaceutical antibodies in patients.

Monoclonal antibodies (mAbs) may be used as biopharmaceuticals to treat various diseases, ranging from oncology to inflammatory and cardiovascular affections. Trustworthy analytical methods are necessary to study their pharmacokinetics, both during their development and in post-marketing studies. Because biopharmaceuticals are macromolecules, ligand-binding assays (both immunoassays and bioassays)...

Basics of Sterile Compounding: Manipulating Peptides and Proteins.

Biopharmaceuticals contain primary and secondary structure, which offer few problems. It is the tertiary structure that causes problems, resulting in both physical and chemical stability issues. The thrust of this article is to share briefly what can be done to minimize these problems.

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.

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