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Biotechnology Products Research

06:26 EST 20th February 2017 | BioPortfolio

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.

Evaluation of changes in promoters, use of UCOES and chain order to improve the antibody production in CHO cells.

Therapy with biopharmaceuticals, mainly recombinant antibodies, offers patients higher life expectancy and better life quality than pharmacologic therapy. Countries with the highest scientific development are investing in this kind of therapy, and this is why the optimization of the production of these recombinant proteins would lead to their higher production and lower costs of the final product....

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.

Biosimilars in Inflammatory Bowel Disease (IBD): Experiences and perceptions of german gastroenterologists.

The European Medicines Agency (EMA) recently approved the first anti-TNF-alpha biosimilar for infliximab (CT-P13) (trade names: Inflectra(®) and Remsima(®)) in Germany. Over the past year, German gastroenterologists gained experience treating IBD-patients with infliximab biosimilars (IFX-biosimilars). To evaluate their experiences and opinions on biosimilars, we conducted a nationwide online sur...

Quantifying Risks of Asparagine Deamidation and Aspartate Isomerization in Biopharmaceuticals by Computing Reaction Free Energy Surfaces.

Early identification of asparagine deamidation and aspartate isomerization degradation sites can facilitate successful development of biopharmaceuticals. Several knowledge-based models have been proposed to assess these degradation risks. In this contribution, we propose a physics-based approach to identify the degradation sites based on the free energy barriers along the pre-chemical conformation...

Infliximab Biosimilars in the Treatment of Inflammatory Bowel Diseases: A Systematic Review.

Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable. CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant al...

Biosimilars approved for treatment of inflammatory rheumatological diseases.

Safety considerations of biosimilars.

Integrated continuous processing of proteins expressed as inclusion bodies: GCSF as a case study.

Affordability of biopharmaceuticals continues to be a challenge, particularly in developing economies. This has fuelled advancements in manufacturing that can offer higher productivity and better economics without sacrificing product quality in the form of an integrated continuous manufacturing platform. While platform processes for monoclonal antibodies have existed for more than a decade, develo...

Outcomes-Based Pricing as a Tool to Ensure Access to Novel but Expensive Biopharmaceuticals.

Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: results of a French web-based survey.

This study's aims were: 1) to extract a comprehensive overview of the knowledge, experience and opinions of both community pharmacists and hospital pharmacists regarding biosimilar medicines in France; and 2) to identify the perceived problems and solutions to promoting their prescription. A 2015 web-based survey was conducted by the Observatoire des Médicaments, des Dispositifs Médicaux et de l...

Scientific Evidence and Financial Obligations to Ensure Access to Biosimilars for Cancer Treatment.

Biosimilars in Gastroenterology - how much uncertainly is ethically acceptable?

Biosimilars use raises uncertainties with regards to efficacy despite potentially significant cost reductions. This requires a classical harm-benefit analysis. Important stakeholders include physicians and patients, companies producing biologica (drugs containing biotechnology-derived proteins as active substance), and companies producing biosimilars, as well as health insurance companies and poli...

Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians.

The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 years in order t...

Practical aspects in the use of biosimilar insulins.

Following the market authorization of the first insulin biosimilar in 2014, further approvals are to be expected due to patent expiry of several originator insulins. Knowledge of the manufacturing and the characteristics of these pharmaceutical products is important for their rationale and safe use by the physician, the pharmacist and the patient.Biosimilars are not generics, but similar or compar...

Biosimilars in oncology: a therapeutic alternative to the reference products?

Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as tho...

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