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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
Masaki Iino, Takeo Yamamoto
Three biosimilar filgrastim products are currently available in Japan. Among these, the safety and efficacy of two imported drugs for autologous peripheral blood stem cell harvest (autoPBSCH) and autologous peripheral blood stem cell transplantation (autoPBSCT) have been studied widely; however, evidence of the safety and efficacy of domestically manufactured filgrastim is limited. Therefore, we compared the efficacy and safety of domestic biosimilar filgrastim (BF1, n=23) with those of originator filgrastim (OF, n=21) for autoPBSCH and autoPBSCT...
2018: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
Stanley B Cohen, Alberto Alonso-Ruiz, Piotr A Klimiuk, Eric C Lee, Nuala Peter, Ivo Sonderegger, Deepak Assudani
OBJECTIVE: To demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira. METHODS: Patients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study. At week 24, patients were rerandomised to continue BI 695501 or Humira, or switch from Humira to BI 695501. The coprimary endpoints were the percentage of patients achieving the American College of Rheumatology 20% response criteria (ACR20) at weeks 12 and 24...
March 7, 2018: Annals of the Rheumatic Diseases
Yi Zhao, Yu-Wei Chang, Shein-Chung Chow
For approval of biosimilar products, the U.S. Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the-evidence for assessing biosimilarirty between a proposed biosimilar product and its corresponding innovative (reference) biologic product. The stepwise approach starts with the assessment of analytical similarity of critical quality attributes (CQAs) for structural/physicochemical and functional properties in the manufacturing process of biosimilar products. For Tier 1 CQAs which are most relevant to clinical outcomes, the FDA recommends an equivalence test be performed for similarity assessment based on an equivalence acceptance criterion (EAC)...
March 7, 2018: Journal of Biopharmaceutical Statistics
Petra Baji, László Gulácsi, Valentin Brodszky, Zsuzsanna Végh, Silvio Danese, Peter M Irving, Laurent Peyrin-Biroulet, Stefan Schreiber, Fanni Rencz, Péter L Lakatos, Márta Péntek
Background: In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking. Objective: The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries. Methods: A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon...
March 2018: United European Gastroenterology Journal
Colin W Howden, Gary R Lichtenstein
No abstract text is available yet for this article.
March 3, 2018: Gastroenterology
Ramesh Palaparthy, Chandrasekhar Udata, Steven Y Hua, Donghua Yin, Chun-Hua Cai, Stephanie Salts, Muhammad I Rehman, Joseph McClellan, Xu Meng
BACKGROUND: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/ GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. METHODS: In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively...
March 5, 2018: Expert Review of Clinical Immunology
Xavier Pivot, Jean Paul Deslypere, Lisa Soyeon Park, Michael Jinwoo Kim, Wonjae Lee, Jeonghyeon Lee
PURPOSE: This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*. METHODS: In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC0-∞ . Equivalence was determined by using the predefined margins of 0...
March 1, 2018: Clinical Therapeutics
Ben Cowper, Xiang Li, Lei Yu, Yong Zhou, W H Fan, C M Rao
Recombinant, human, erythropoietin (rhEPO) is a glycoprotein hormone which is prescribed throughout the world to treat anaemia caused by chronic kidney disease or chemotherapy. rhEPO is at the forefront of the recent emergence of biosimilar medicines, with numerous products now available worldwide. Due to its complex glycosylation profile, which has a crucial influence upon biological activity, therapeutic rhEPO preparations must be closely monitored to ensure consistency, safety and efficacy. Here, we have compared twelve rhEPO preparations from eleven manufacturers in China and one in Japan, measuring in vivo biological activity and exploring its relationship with glycosylation through sialic acid content determination, isoform distribution via capillary electrophoresis (CE), O-glycan profiling, and N-glycan mapping using a novel anion-exchange/hydrophilic interaction chromatography-mass spectrometry (AEX/HILIC-MS) approach...
February 24, 2018: Journal of Pharmaceutical and Biomedical Analysis
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval...
March 2, 2018: Clinical Drug Investigation
Hillel P Cohen, Andrew Blauvelt, Robert M Rifkin, Silvio Danese, Sameer B Gokhale, Gillian Woollett
INTRODUCTION: To evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars). METHODS: A systematic search was conducted using the Medline® and Embase® databases up to 30 June 2017 employing specific medical subject heading terms...
March 3, 2018: Drugs
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