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Biotechnology Products Research

21:12 EST 18th January 2017 | BioPortfolio

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...

Biosimilars and the efficiency principle.

Biosimilars are subject to the efficiency evaluation according to section 106 Social Code Book Five (SGB V). The specific evaluation method influences the physician's prescription behaviour. In the case of an individual prescription limit evaluation (Richtgrößenprüfung), the prescription of biosimilars would usually not result in recourse but, as a start, in the initiation of the evaluation pro...

Biologics or biosimilars: What is the difference?

Author reply: Biologics or biosimilars: What is the difference?

Biosimilars in inflammatory bowel disease.

After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT‑P13 was approved for indications in Crohn's disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience sin...

Opportunities and challenges of extrapolation for biosimilars.

Although biosimilars approved in the European Union have proved to be safe and efficacious, their licensing requirements continue to be disputed by medical professionals. In particular, extrapolation to indications of the originator without one's own clinical data of the biosimilar is controversial. Conceptually, the development of biosimilars is derived from that of generics. However, due to thei...

Mass spectrometric characterisation of darbepoetin alfa biosimilars with C-terminal arginine residues.

Human erythropoietin (EPO) and recombinant human EPO (rEPO) are approximately 30-kDa glycosylated proteins comprising 165 amino acids. Darbepoetin alfa (NESP) is a glycosylated protein encompassing five changes in the amino acid sequence of human EPO, which contains two extra sugar chains. NESP is under patent protection in the USA until May 2024 and in Europe until July 2016, which suggests that ...

Camelid VHH affinity ligands enable separation of closely related biopharmaceuticals.

Interest in new and diverse classes of molecules such as recombinant toxins, enzymes, and blood factors continues to grow for use a biotherapeutics. Compared to monoclonal antibodies, these novel drugs typically lack a commercially available affinity chromatography option, which leads to greater process complexity, longer development timelines, and poor platformability. To date, for both monoclona...

Glycosylation of Monoclonal Antibody Products: Current Status and Future Prospects.

Protein based therapeutics have started to dominate the pharmaceutical landscape primarily due to the high efficacy that they have demonstrated against complex diseases. Despite the significant success, issues with regards to safety, efficacy and quality of biotherapeutics have been a point of considerable debate and concern among the various stakeholders. The correlation between the glycoform pro...

Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.

Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosim...

Biosimilars for Psoriasis: Clinical Studies to Determine Similarity.

Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine biosimilarity. In this review written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a ...

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