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Biotechnology Products Research

11:37 EDT 25th March 2017 | BioPortfolio

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...

Protein epitope mimetic macrocycles as biopharmaceuticals.

Fully synthetic medium-sized macrocyclic peptides mimicking the key β-hairpin and α-helical protein epitopes relevant in many protein-protein interactions have emerged as a novel class of drugs with the potential to fill an important gap between small molecules and proteins. Conformationally stabilized macrocyclic scaffolds represent ideal templates for medicinal chemists to incorporate bioactiv...

Biosimilars: implications for rheumatoid arthritis therapy.

Abbreviated pathways for the approval of biosimilars have been established in the European Union (EU), the United States, and other countries. Biosimilar TNF inhibitors have been available in South Korea and the EU since 2012 and 2013, respectively, and the first biosimilar infliximab was introduced to the clinic in the United States in November 2016. Five TNF inhibitor biosimilars have now been a...

Advances in rheumatoid arthritis.

There are now eight approved biological disease-modifying antirheumatic drugs (bDMARDs), two biosimilars and one targeted synthetic DMARD in Australia with a number of new products and biosimilars in the pipeline. bDMARDs have excellent efficacy, especially when combined with traditional DMARDs, and a well characterised but manageable safety profile. These expanded therapeutic options have revolut...

Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy.

To evaluate the benefit/risk profile of epoetin α biosimilar with the erythropoiesis-stimulating agents (ESAs) originators when administered to naïve patients from clinical practice.

Editorial (Thematic Issue : Emerging Biopharmaceuticals from Bioactive Peptides).

Reversible Macrocyclization of Peptides with a Conjugate Acceptor.

Macrocyclic peptides are an increasingly important class of biopharmaceuticals. A new method of macrocyclization is reported that involves reaction of the N-terminal amine and thiol side chain of cysteine with a Meldrum's acid derived conjugate acceptor. This reaction, which utilizes naturally occurring amino acids and requires no orthogonal protection of side chains, can also be reversed to yield...

The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects.

Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes...

Ion Mobility-Mass Spectrometry Reveals a Dipeptide That Acts as a Molecular Chaperone for Amyloid β.

Previously, we discovered and structurally characterized a complex between amyloid β 1-40 and the neuropeptide leucine enkephalin. This work identified leucine enkephalin as a potentially useful starting point for the discovery of peptide-related biotherapeutics for Alzheimer's disease. In order to better understand such complexes that are formed in vitro, we describe here the analysis of a serie...

A survey of pharmacists' knowledge and views of biosimilars in Quebec and France.

The objective of this study was to survey pharmacists' knowledge and views of biosimilars in Quebec and France.

Biopharmaceuticals: reference products and biosimilars to treat inflammatory diseases.

Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared to low molecular chemically synthesized drugs, production of biopharmaceuticals is much more complex and routes of administration and pharmacokinetics differ. Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases such as psoriasis,...

Biosimilars in the European Union from comparability exercise to real world experience: What we achieved and what we still need to achieve.

Characterization and QC of biopharmaceuticals by MS-based 'multi-attribute method': advantages and challenges.

An Important Step Forward for Biosimilars in Cancer Treatment.

New Insulins, Biosimilars, and Insulin Therapy.

Combining Therapeutic Drug Monitoring with Biosimilars, a Strategy to Improve the Efficacy of Biologicals for Treating Inflammatory Bowel Diseases at an Affordable Cost.

Biologicals provide a tight disease control but not all patients respond favourably to treatment. Some patients do not respond at all (primary non-responders), while other patients respond initially but show loss of response over time (secondary non-responders). Drug concentrations in the serum of patients can be monitored and correlated with biological, clinical or endoscopic response. Therapeuti...

Does the Introduction of Biosimilars Change Our Understanding about Treatment Modalities for Inflammatory Bowel Disease?

Biological agents, mainly tumor necrosis factor-α inhibitors, play an important role in the treatment of inflammatory bowel disease (IBD). These drugs are expensive and constitute a major cost in the IBD care. In 2013, the first biosimilar monoclonal antibody, infliximab (IFX), was approved in the EU. Key Messages: There has been considerable skepticism regarding the use of biosimilars. Both clin...

History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology.

Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the...

Engineered Probiotics: Applications and Biological Containment.

Bioengineered probiotics represent the next generation of whole cell-mediated biotherapeutics. Advances in synthetic biology, genome engineering, and DNA sequencing and synthesis have enabled scientists to design and develop probiotics with increased stress tolerance and the ability to target specific pathogens and their associated toxins, as well as to mediate targeted delivery of vaccines, drugs...

Patent litigation could make 2017 no 'dancing' matter.

No matter how you slice it, 2016 was a banner year for biosimilars. Still, the high-stakes marketing, regulatory, and legal combat between originators and biosimilars is a long way from over. So far, the originators have been able to hold their ground and thwart the launch of biosimilars with patent lawsuits.

Regional Differences in the Prescription of Biologics for Psoriasis in Sweden: A Register-Based Study of 4168 Patients.

Observational studies suggest an inequitable prescription of biologics in psoriasis care, which may be attributed to geographical differences in treatment access. Sweden regularly ranks high in international comparisons of equitable healthcare, and is, in connection with established national registries, an ideal country to investigate potential inequitable access.

Portuguese Position Paper on the Use of Biosimilars in Psoriasis.

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