Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel (R))

Hofmann Hans-Peter; Kronthaler Ulrich; Fritsch Cornelius; Grau Roger; Mueller Stefan O.; Mayer Robert; Seidl Andreas; Da Silva Antonio

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Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel (R))

机译：拟定的带有依那西普的依那西普生物仿制药GP2015的表征和非临床评估（Enbrel（R））

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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 (R)).

机译：背景和目的：生物仿制药是经过批准的生物制剂，在质量，安全性和功效方面可与原始产品媲美。本文中，作者描述了旨在确定GP2015和鼻祖依那西普（Enbrel（R））的生物相似性的功能性和非临床研究。

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《Expert opinion on biological therapy》 |2016年第10期|共11页
作者
Hofmann Hans-Peter; Kronthaler Ulrich; Fritsch Cornelius; Grau Roger; Mueller Stefan O.; Mayer Robert; Seidl Andreas; Da Silva Antonio;
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正文语种 eng
中图分类治疗学;
关键词
TNF-alpha; biosimilars; disease-modifying drugs; etanercept; GP2015; Enbrel;

机译：TNF-α;生物仿制药;疾病修饰药物;依那西普;GP2015;Enbrel;

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1. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel (R)) [J] . Hofmann Hans-Peter, Kronthaler Ulrich, Fritsch Cornelius, Expert opinion on biological therapy . 2016,第10期

机译：拟定的带有依那西普的依那西普生物仿制药GP2015的表征和非临床评估（Enbrel（R））
2. The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar [J] . Strand Vibeke, Girolomoni Giampiero, Schiestl Martin, Current medical research and opinion . 2017,第6期

机译：关于GP2015的发展和评估的总体证据方法，提出的伊纳西普生物酸
3. GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes [J] . Richter, Oliver, Skerjanec, British journal of clinical pharmacology . 2017,第4期

机译：GP2015，拟议的依那西普生物仿制药：与参考产品的药代动力学相似性以及自动注射器与预装注射器的比较
4. CHARACTERIZATION AND COMPARISON OF O-GLYCOSYLATION BETWEEN THE INNOVATOR AND A BIOSIMILAR OF ETANERCEPT [C] . Stephane Houel, Ying Qing Yu, Jonathan P. Williams, American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2013

机译：创新者与生物糖基化与依托西普生物纤维化的表征及比较
5. A Health Technology Assessment of a Proposed Biosimilar for the Treatment of Chemotherapy Induced Febrile Neutropenia: A U.S. Payer Perspective. [D] . Vaidya, Neel. 2013

机译：拟议的生物仿制药用于化学疗法诱导的发热性中性粒细胞减少症的健康技术评估：美国付款人观点。
6. Multiple switches between GP2015 an etanercept biosimilar with originator product do not impact efficacy safety and immunogenicity in patients with chronic plaque‐type psoriasis: 30‐week results from the phase 3 confirmatory EGALITY study [O] . S. Gerdes, D. Thaçi, C.E.M. Griffiths, -1

机译：依那西普生物仿制药与原始产品GP2015之间的多次切换不会影响慢性斑块状牛皮癣患者的功效安全性和免疫原性：3期临床试验30周证实性EGALITY研究
7. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®) [O] . Hans-Peter Hofmann, Ulrich Kronthaler, Cornelius Fritsch, 2016

机译：提出的Etanercept BioSimilar GP2015具有发起者entanErcept的表征和非临床评估（eNbrel®）
8. Proposed Nomination of Sites for Site Characterization and Recommendation of Issues for Environmental Assessments and Site Characterization Plans. Technical Report. Summary of Issues and Concerns Expressed During the April-May 198 [R] . Ford, W. 1983

机译：建议提名用于场地定性的场地和建议环境评估和场地特征计划的问题。技术报告。关于在1985年4月至5月期间出现的问题和关注的摘要

Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel (R))

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