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D Franchimont, M Ferrante, E Louis, M De Vos, O Dewit, P Van Hootegem, T Moreels, C Liefferinckx, P Bossuyt, F Baert, J F Rahier, S Vermeire
No abstract text is available yet for this article.
January 2018: Acta Gastro-enterologica Belgica
Ali McBride, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham, Sanjeev Balu
No abstract text is available yet for this article.
March 21, 2018: Journal of Medical Economics
John Fitton, Alessandro Giollo, Maya H Buch
Rheumatoid arthritis is a common inflammatory joint disease with a myriad of systemic manifestations. Over the last 20 years its treatment has been revolutionised by the introduction of a number of different biologic drugs, including the TNF-receptor Fc fusion protein, Etanercept. However, these drugs are expensive and their widespread use puts a financial burden on healthcare systems. As many biologic treatments begin to come off patent new 'biosimilar' versions are being developed which can lead to significant cost savings...
April 2018: Expert Opinion on Biological Therapy
Yeong Ran Jeong, Rae Ung Jeong, Jeong Hyun Son, Joon Cheol Kwon, Saem Jung, Mi A Song, Jin Ah Hwang, Gyun Min Lee
BACKGROUND: For regulatory approval, the comparability of a biosimilar product to an originator product should be ensured through thorough physicochemical and biological characterization. OBJECTIVE: To evaluate the biosimilarity between LBDE, the proposed biosimilar darbepoetin alfa, and NESP® , its originator, we performed a comprehensive physicochemical and biological characterization study. METHODS: Primary and higher-order protein structures were analyzed using Lys-C peptide mapping with liquid chromatography-mass spectrometry (LC-MS), disulfide bond identification, circular dichroism, and fluorescence spectroscopy...
March 19, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
V Moalic-Allain
Hematopoietic stem cell transplantation is a common procedure potentially beneficial to many individuals with cancer, hematological, or inherited disorders, and has highlighted the need of related or unrelated donors to perform allograft. Donation of hematopoietic stem cells, either through bone marrow harvest or peripheral blood stem cell collection, is well-established and widespread. Over the past two decades, the peripheral blood stem cell collection by aphaeresis has become the main source of hematopoietic stem cells for transplantation, due to faster engraftment and practicability and lower risk of relapse for high-risk patients...
March 16, 2018: Transfusion Clinique et Biologique: Journal de la Société Française de Transfusion Sanguine
Szilard Kiss, Howard F Fine, Jennifer Krawitz
No abstract text is available yet for this article.
March 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
Neungseon Seo, Alla Polozova, Mingxuan Zhang, Zachary Yates, Shawn Cao, Huimin Li, Scott Kuhns, Gwendolyn Maher, Helen J McBride, Jennifer Liu
ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular endothelial growth factor A, inhibiting endothelial cell proliferation and new blood vessel formation, thereby leading to tumor vasculature normalization. The ABP 215 analytical similarity assessment was designed to assess the structural and functional similarity of ABP 215 and bevacizumab sourced from both the United States (US) and the European Union (EU). Similarity assessment was also made between the US- and EU-sourced bevacizumab to assess the similarity between the two products...
March 19, 2018: MAbs
Jose-Manuel Carrascosa, Ira Jacobs, Danielle Petersel, Robert Strohal
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis...
March 16, 2018: Dermatology and Therapy
Mark Bensink, Christine Edwards, Charles Bowers, Jon Campbell
No abstract text is available yet for this article.
March 16, 2018: Journal of Medical Economics
Andras Inotai, Marcell Csanadi, Guenka Petrova, Maria Dimitrova, Tomasz Bochenek, Tomas Tesar, Kristina York, Leos Fuksa, Alexander Kostyuk, Laszlo Lorenzovici, Vitaly Omelyanovskiy, Katalin Egyed, Zoltan Kalo
This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars...
2018: BioMed Research International
Lisette Binkhorst, Annemieke Sobels, Rogier Stuyt, Elsbeth M Westerman, Rachel L West
OBJECTIVE: Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab. PATIENTS AND METHODS: At two large general hospitals in The Netherlands, adult patients with a diagnosis of Crohn's disease or ulcerative colitis being treated with Remicade were asked to switch to the biosimilar infliximab (CT-P13)...
March 13, 2018: European Journal of Gastroenterology & Hepatology
Tomohide Yamada, Ryuichi Kamata, Kotomi Ishinohachi, Nobuhiro Shojima, Sophia Ananiadou, Hisashi Noma, Toshimasa Yamauchi, Takashi Kadowaki
Biosimilar insulins have expanded treatment options for diabetes. We compared clinical efficacy and safety between biosimilar and originator insulins by meta-analysis. Random effects meta-analysis was performed on randomized controlled trials comparing biosimilar and originator insulins in adults with diabetes from electronic databases up to December 2017. Ten trials (4,935 patients) were assessed (2 each for LY2963016, MK-1293, Mylan's insulin glargine, and SAR342434, and 1 each for FFP-112 and Basalog). Meta-analysis revealed no differences between long-acting biosimilar and originator insulins for reduction of hemoglobin A1c at 24 weeks (0...
March 14, 2018: Diabetes, Obesity & Metabolism
Johanna Mielke, Heinz Schmidli, Byron Jones
For the approval of biosimilars, it is, in most cases, necessary to conduct large Phase III clinical trials in patients to convince the regulatory authorities that the product is comparable in terms of efficacy and safety to the originator product. As the originator product has already been studied in several trials beforehand, it seems natural to include this historical information into the showing of equivalent efficacy. Since all studies for the regulatory approval of biosimilars are confirmatory studies, it is required that the statistical approach has reasonable frequentist properties, most importantly, that the Type I error rate is controlled-at least in all scenarios that are realistic in practice...
March 13, 2018: Biometrical Journal. Biometrische Zeitschrift
Federico Argüelles Arias, Joaquín Hinojosa Del Val, Isabel Vera Mendoza
In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.
March 12, 2018: Revista Española de Enfermedades Digestivas
Kimberly Blackwell, Joseph Gligorov, Ira Jacobs, Chris Twelves
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+ ) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2+ metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2+ MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease...
February 2, 2018: Clinical Breast Cancer
Ditlev Birch, Ragna G Diedrichsen, Philip C Christophersen, Huiling Mu, Hanne M Nielsen
The absence of a surface-lining mucus layer is a major pitfall for the Caco-2 epithelial model. However, this can be alleviated by applying biosimilar mucus (BM) to the apical surface of the cell monolayer, thereby constructing a mucosa mimicking in vivo conditions. This study aims to elucidate the influence of BM as a barrier towards exogenic compounds such as permeation enhancers, and components of fed state simulated intestinal fluid (FeSSIF). Caco-2 cell monolayers surface-lined with BM were exposed to several compounds with distinct physicochemical properties, and the cell viability and permeability of the cell monolayer was compared to that of cell monolayers without BM and well-established mucus-secreting epithelial models (HT29 monolayers and HT29/Caco-2 co-culture monolayers)...
March 7, 2018: European Journal of Pharmaceutical Sciences
Ashima Sharma, Tapan K Chaudhuri
Human serum albumin one of the most demanded proteins possess an array of clinical and biotechnological applications. Currently, the prime source for HSA production is the human blood which possesses the risk of pathogen contamination and is limited. Thus, there exists an indispensable need to promote non-animal derived HSA production. In the present work, we have exploited the opportunity and promoted the preparation of pathogen-free rHSA from the E. coli host which is blessed with numerous advantages like scalability, cost-effectiveness etc...
March 7, 2018: Journal of Biotechnology
Matic Grom, Mirijam Kozorog, Simon Caserman, Andrej Pohar, Blaž Likozar
Protein A-based affinity chromatography is a highly-efficient separation method to capture, purify and isolate biosimilar monoclonal antibodies (mAb) - an important medical product of biopharmaceutical industrial manufacturing. It is considered the most expensive step in purification downstream operations; therefore, its performance optimization offers a great cost saving in the overall production expenditure. The biochemical mixture-separating specific interaction experiments with Chinese hamster ovary (CHO) cell culture harvest, containing glycosylated extracellular immunoglobulins (Ig), were made using five different state-of-the-art commercial resins...
March 1, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
R Ríos León, A Jaureguizar Oriol, A López-Sanromán, D Jiménez Castro, R Nieto Royo, A Albillos Martínez
No abstract text is available yet for this article.
March 5, 2018: Gastroenterología y Hepatología
Peijuan Zhu, Sherwin K B Sy, Andrej Skerjanec
This article provides an overview of four case studies to demonstrate the utility of pharmacometric analysis in biosimilar development to help design sensitive clinical pharmacology studies for the demonstration of biosimilarity. The two major factors that determine the sensitivity of a clinical pharmacokinetic/pharmacodynamic (PK/PD) study to demonstrate biosimilarity are the size of the potential difference to be detected (signal) and the inter-subject variability (noise), both of which can be characterized and predicted using pharmacometric approaches...
March 7, 2018: AAPS Journal
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