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https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#1
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27869161/therapeutic-targeting-of-necroptosis-by-smac-mimetic-bypasses-apoptosis-resistance-in-acute-myeloid-leukemia-cells
#2
C Safferthal, K Rohde, S Fulda
Resistance to apoptosis, for example due to overexpression of Inhibitor of Apoptosis (IAP) proteins, is associated with poor prognosis in acute myeloid leukemia (AML). Here, we identify that Smac mimetics such as BV6, which antagonizes IAP proteins, elicit necroptosis in AML cells, in which apoptosis is inhibited pharmacologically by caspase inhibitors or genetically by caspase-8 knockdown. Importantly, BV6 triggers necroptosis also in apoptosis-resistant patient-derived AML blasts, underlining the clinical relevance of our findings...
November 21, 2016: Oncogene
https://www.readbyqxmd.com/read/27817152/patient-perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-findings-from-a-patient-survey-in-europe
#3
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Benepali(®) was the first etanercept (Enbrel(®)) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. To determine whether patients' perceptions were similar to those of the nurses, this survey evaluated patients' perceptions and preferences of the Benepali autoinjector versus the Enbrel MYCLIC autoinjector in the same five European countries...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27787890/the-egality-study-a-confirmatory-randomised-double-blind-study-comparing-the-efficacy-safety-and-immunogenicity-of-gp2015-a-proposed-etanercept-biosimilar-versus-the-originator-product-in-patients-with-moderate-to-severe-chronic-plaque-type-psoriasis
#4
C E M Griffiths, D Thaçi, S Gerdes, P Arenberger, G Pulka, K Kingo, J Weglowska, N Hattebuhr, J Poetzl, H Woehling, G Wuerth, M Afonso
BACKGROUND: GP2015 is a proposed etanercept biosimilar. OBJECTIVE: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and etanercept originator (ETN, Enbrel(®) ) in patients with moderate to severe chronic plaque-type psoriasis. METHODS: 531 eligible patients were randomised 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously. Patients with a 50% improvement in psoriasis area and severity index (PASI 50) at week 12 were re-randomised to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of 3 treatment switches between GP2015 and ETN until week 30...
October 27, 2016: British Journal of Dermatology
https://www.readbyqxmd.com/read/27780088/real-time-label-free-detection-and-kinetic-analysis-of-etanercept-protein-a-interactions-using-quartz-crystal-microbalance
#5
Evan A Dubiel, Bruno Martin, Sylvain Vigier, Patrick Vermette
A quartz crystal microbalance (QCM) was constructed to assess if such a biosensor has value as a complementary real-time label-free analysis platform for the biopharmaceutical industry. This was achieved through modifying QCM crystals with a low-fouling carboxymethyl-dextran layer bearing Protein A, and then injecting solutions containing Etanercept (i.e., Enbrel(®)) into the QCM chambers. The kinetics of Enbrel(®) - Protein A interactions was modeled using the Langmuir binding model and Enbrel(®) concentrations between 0...
October 19, 2016: Colloids and Surfaces. B, Biointerfaces
https://www.readbyqxmd.com/read/27747586/erratum-to-perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-a-new-european-union-approved-etanercept-biosimilar-benepali-%C3%A2-versus-etanercept-enbrel-%C3%A2-findings-from-a-nurse-survey-in-europe
#6
https://www.readbyqxmd.com/read/27747519/perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-a-new-european-union-approved-etanercept-biosimilar-benepali-%C3%A2-versus-etanercept-enbrel-%C3%A2-findings-from-a-nurse-survey-in-europe
#7
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Enbrel(®) (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali(®): manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe...
June 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27709444/the-usage-of-biological-dmards-and-clinical-remission-of-rheumatoid-arthritis-in-china-a-real-world-large-scale-study
#8
Yuan An, Tian Liu, Dongyi He, Lijun Wu, Juan Li, Yi Liu, Liqi Bi, Bin Zhou, Changsong Lin, Lan He, Xiangyuan Liu, Xiaofeng Li, Niansheng Yang, Zhuoli Zhang, Hui Song, Wei Wei, Jing Liu, Yu Bi, Zhanguo Li
The aims of this study are to characterize the biological disease-modifying antirheumatic drug (bDMARD) usage patterns in real-life and examine the remission rate of rheumatoid arthritis (RA) patients receiving bDMARDs in routine clinical practice in China. Consenting RA patients (≥18 years) from 15 teaching hospitals and receiving marketed bDMARDs were included. In total, 802 patients (81.3 % women, 49.0 ± 13.9 years) were included; 89.5 % were receiving a combination of bDMARDs and conventional synthetic DMARDs (csDMARDS), whereas 10...
October 5, 2016: Clinical Rheumatology
https://www.readbyqxmd.com/read/27643935/changes-of-microrna-1-15b-and-21-levels-in-irradiated-rat-hearts-after-treatment-with-potentially-radioprotective-drugs
#9
B Kura, C Yin, K Frimmel, J Krizak, L Okruhlicova, R C Kukreja, J Slezak
The aim of this study was to measure expression levels of microRNAs (miRNAs) (miRNA-1, -15b and -21) in the rat myocardium after a single dose of ionizing radiation (6-7 Gy/min, total 25 Gy). The rats were treated with selected drugs (Atorvastatin, acetylsalicylic acid (ASA), Tadalafil, Enbrel) for six weeks after irradiation. MiRNAs levels were measured by RT-qPCR. Irradiation down-regulated miRNA-1 in irradiated hearts. In Tadalafil- and Atorvastatin-treated groups, miRNA-1 expression levels were further decreased compared with irradiated controls...
September 19, 2016: Physiological Research
https://www.readbyqxmd.com/read/27588378/periodontal-conditions-in-juvenile-idiopatic-arthritis
#10
Cinzia Maspero, Lucia Giannini, Vera Carletti, Guido Galbiati, Chiara Prevedello, Giampietro Farronato
BACKGROUND: The possible relationship between periodontitis and Juvenile Idiopathic Arthritis is now mostly unknown but there are common characteristics in both diseases. The purpose of this study is to evaluate Etanercept (Enbrel®) effects on periodontal conditions of children affected by Juvenile Idiopathic Arthritis. METHODS: For this study three group of patients were selected. The first one is represented by Juvenile Idiopathic Arthritis subjects in pharmacologic therapy with Etanercept(Enbrel ®)...
September 2, 2016: Minerva Stomatologica
https://www.readbyqxmd.com/read/27527221/modulation-of-human-airway-barrier-functions-during-burkholderia-thailandensis-and-francisella-tularensis-infection-running-title-airway-barrier-functions-during-bacterial-infections
#11
Cornelia Blume, Jonathan David, Rachel E Bell, Jay R Laver, Robert C Read, Graeme C Clark, Donna E Davies, Emily J Swindle
The bronchial epithelium provides protection against pathogens from the inhaled environment through the formation of a highly-regulated barrier. In order to understand the pulmonary diseases melioidosis and tularemia caused by Burkholderia thailandensis and Fransicella tularensis, respectively, the barrier function of the human bronchial epithelium were analysed. Polarised 16HBE14o- or differentiated primary human bronchial epithelial cells (BECs) were exposed to increasing multiplicities of infection (MOI) of B...
August 3, 2016: Pathogens
https://www.readbyqxmd.com/read/27473492/applications-of-an-automated-and-quantitative-ce-based-size-and-charge-western-blot-for-therapeutic-proteins-and-vaccines
#12
Richard R Rustandi, Melissa Hamm, Catherine Lancaster, John W Loughney
Capillary Electrophoresis (CE) is a versatile and indispensable analytical tool that can be applied to characterize proteins. In recent years, labor-intensive SDS-PAGE and IEF slab gels have been replaced with CE-SDS (CGE) and CE-IEF methods, respectively, in the biopharmaceutical industry. These two CE-based methods are now an industry standard and are an expectation of the regulatory agencies for biologics characterization. Another important and traditional slab gel technique is the western blot, which detects proteins using immuno-specific reagents after SDS-PAGE separation...
2016: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27463856/characterization-and-non-clinical-assessment-of-the-proposed-etanercept-biosimilar-gp2015-with-originator-etanercept-enbrel-%C3%A2
#13
Hans-Peter Hofmann, Ulrich Kronthaler, Cornelius Fritsch, Roger Grau, Stefan O Müller, Robert Mayer, Andreas Seidl, Antonio Da Silva
BACKGROUND AND OBJECTIVE: Biosimilars are approved biologics that are comparable to an originator product with respect to quality, safety and efficacy. Herein, the authors describe the functional and non-clinical studies designed to determine the biosimilarity of GP2015 and originator etanercept (Enbrel®). METHODS: The development of an Enbrel biosimilar (GP2015) involved extensive characterization of the originator. A step-wise target-directed and iterative technical development program involving state-of-the-art functional characterization studies and non-clinical evaluations (pharmacokinetics, pharmacodynamics and safety/toxicology) was applied with the aim of confirming that GP2015 is comparable to originator (Enbrel) at the non-clinical level...
October 2016: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27455991/etanercept-sb4-a-review-in-autoimmune-inflammatory-diseases
#14
Celeste B Burness, Sean T Duggan
Etanercept (SB4) [Benepali(®)], a tumour necrosis factor inhibitor that is a biosimilar of reference etanercept (Enbrel(®)), is approved in the EU for use in all adult indications for which reference etanercept is approved, namely rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), psoriatic arthritis, and plaque psoriasis. The approval of etanercept (SB4) was based on the results of stringent comparability exercises designed to demonstrate similarity to reference etanercept in terms of quality, biological activity, efficacy, safety, and immunogenicity...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27259948/protective-effect-of-etanercept-an-inhibitor-of-tumor-necrosis-factor-%C3%AE-in-a-rat-model-of-retinal-ischemia
#15
Hyoung Won Bae, Naeun Lee, Gong Je Seong, Seungsoo Rho, Samin Hong, Chan Yun Kim
BACKGROUND: To assess the neuroprotective effect of etanercept (Enbrel®) which is a commercialized Tumor necrosis factor-α (TNF-α) inhibitor on axonal injury in an animal model of acute ischemia. METHODS: Acute ischemia was induced by intraocular pressure elevation in 36 rats. The treatment groups underwent subcutaneous injection of etanercept (0.3 or 1.0 mg/kg) three times per week up to 4 weeks. The control groups were treated in the same manner using the same volume of phosphate-buffered saline (PBS)...
2016: BMC Ophthalmology
https://www.readbyqxmd.com/read/27246928/evaluation-of-the-structural-physicochemical-and-biological-characteristics-of-sb4-a-biosimilar-of-etanercept
#16
Ick Hyun Cho, Nayoung Lee, Dami Song, Seong Young Jung, George Bou-Assaf, Zoran Sosic, Wei Zhang, Yelena Lyubarskaya
A biosimilar is a biological medicinal product that is comparable to a reference medicinal product in terms of quality, safety, and efficacy. SB4 was developed as a biosimilar to Enbrel® (etanercept) and was approved as Benepali®, the first biosimilar of etanercept licensed in the European Union (EU). The quality assessment of SB4 was performed in accordance with the ICH comparability guideline and the biosimilar guidelines of the European Medicines Agency and Food and Drug Administration. Extensive structural, physicochemical, and biological testing was performed with state-of-the-art technologies during a side-by-side comparison of the products...
August 2016: MAbs
https://www.readbyqxmd.com/read/27237733/characterization-and-comparability-of-stress-induced-oxidation-and-deamidation-on-vulnerable-sites-of-etanercept-products
#17
Li-Juan Huang, Chia-Wang Chiang, Yu-Wen Lee, Tzu-Fan Wang, Ching-Chu Fong, Shu-Hui Chen
An etanercept biosimilar, TuNEX(®), was compared to the innovator drug, Enbrel(®), for its reaction to stress-induced oxidation and deamidation, which may affect drug efficacy. A tryptic peptide map of both etanercept products was generated by liquid chromatography (LC) using mass spectrometry (MS) and ultraviolet (UV) spectrophotometry detection methods. The sequence of each modified or non-modified peptide peak was assigned based on accurate measurement of the mass of the protein and analysis utilizing tandem MS...
October 1, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27136625/molluscum-contagiosum-of-the-eyelid-case-report-in-a-man-receiving-methotrexate-and-literature-review-of-molluscum-contagiosum-in-patients-who-are-immunosuppressed-secondary-to-methotrexate-or-hiv-infection
#18
Bryce David Beutler, Philip R Cohen
BACKGROUND: Molluscum contagiosum is a benign viral infection of the skin. Lesions typically present as dome-shaped, flesh-colored, umbilicated papules that range in size from 1 to 5 millimeters in diameter. They are usually asymptomatic, but can become tender or pruritic. Children and immunocompromised adults, including individuals being treated with immunosuppressive drugs, are most susceptible to infection. Single or multiple lesions most commonly appear on the extremities, face, genitals, and trunk...
2016: Dermatology Online Journal
https://www.readbyqxmd.com/read/27135404/the-clinical-effectiveness-and-cost-effectiveness-of-abatacept-adalimumab-etanercept-and-tocilizumab-for-treating-juvenile-idiopathic-arthritis-a-systematic-review-and-economic-evaluation
#19
Jonathan Shepherd, Keith Cooper, Petra Harris, Joanna Picot, Micah Rose
BACKGROUND: Juvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel(®), Pfizer), abatacept (Orencia(®), Bristol-Myers Squibb), adalimumab (Humira(®), AbbVie) and tocilizumab (RoActemra(®), Roche) - with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded)...
April 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/26972584/a-randomized-phase-l-pharmacokinetic-study-comparing-sb4-and-etanercept-reference-product-enbrel%C3%A2-in-healthy-subjects
#20
Yoon Jung Lee, Donghoon Shin, Youngdoe Kim, Jungwon Kang, Anke Gauliard, Rainard Fuhr
AIMS: SB4 has been developed as a biosimilar of etanercept. The primary objective of the present study was to demonstrate the pharmacokinetic (PK) equivalence between SB4 and European Union -sourced etanercept (EU-ETN), SB4 and United States-sourced etanercept (US-ETN), and EU-ETN and US-ETN. The safety and immunogenicity were also compared between the treatments. METHODS: This was a single-blind, three-part, crossover study in 138 healthy male subjects. In each part, 46 subjects were randomized at a 1:1 ratio to receive a single 50 mg subcutaneous dose of the treatments (part A: SB4 or EU-ETN; part B: SB4 or US-ETN; and part C: EU-ETN or US-ETN) in period 1, followed by the crossover treatment in period 2 according to their assigned sequences...
July 2016: British Journal of Clinical Pharmacology
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