云南高校图书馆联盟文献共享服务平台- BIOSIMILAR

BIOSIMILAR: 作品数：32被引量：34H指数：4; 导出分析报告; 相关领域：医药卫生经济管理更多>>; 相关作者：高凯王兰郭玮赵荣生吴晶更多>>; 相关机构：中国食品药品检定研究院上海市医学科学技术情报研究所北京大学北京大学第三医院更多>>; 相关期刊：《药学学报》《World Journal of Nephrology》《Journal of Chinese Pharmaceutical Sciences》《中国医药生物技术》更多>>; 相关基金：国家自然科学基金国家科技重大专项更多>>

Comparison and Suggestions on the Registration and Regulation of Biosimilars between China and the USA: 《Asian Journal of Social Pharmacy》2025年第1期28-37,共10页Cao Yizhi Lian Guiyu; Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry a...; 关键词：BIOSIMILAR registration and regulation REVIEW approve

Real-world experience and long-term outcomes of a mandatory nonmedical switch of adalimumab originator to biosimilars in inflammatory bowel disease: 《World Journal of Gastroenterology》2024年第46期4904-4913,共10页Jeremy Liu Chen Kiow Thomas Hoang Harjot K Bedi Zhina Majdzadeh Ardekani Daniel Rosenfeld Marica Reise-Filteau Brian Bressler Yvette Leung Greg Rosenfeld; BACKGROUND Over the last decade,the treatment options for inflammatory bowel disease(IBD)have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate infl...; 关键词：Inflammatory bowel disease Ulcerative colitis Crohn’s disease BIOLOGICS ADALIMUMAB Biosimilar switch

Outcomes of a 12-month course of early and late rituximab BCD020 biosimilar administration in juvenile systemic lupus erythematosus:A retrospective study: 《World Journal of Nephrology》2024年第4期81-90,共10页Elvira Kalashnikova Eugenia Isupova Ekaterina Gaidar Natalia Lubimova Lyubov Sorokina Irina Chikova Maria Kaneva Rinat Raupov Olga Kalashnikova Damir Aliev Inna Gaydukova Mikhail Kostik; Supported by Ministry of Science and Higher Education of the Russian Federation,No.075-15-2022-301;the Russian Science Foundation Grant,No.22-45-08004.; BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve dis...; 关键词：Systemic lupus erythematosus RITUXIMAB Rituximab BCD020 biosimilar Anti-CD-20 BIOLOGIC Children

Cancer treatment with biosimilar drugs:A review: 《Cancer Innovation》2024年第2期45-62,共18页Shilpa Malakar Emmanuel Nuah Gontor Moses YDugbaye Kamal Shah Sakshi Sinha Priya Sutaoney Nagendra Singh Chauhan; Director of AYUSH(Chhattisgarh)for laboratory facilities and National Ayush Mission(NAM)Grant award year 2016-17。; Biosimilars are biological drugs created from living organisms or that contain living components.They share an identical amino-acid sequence and immunogenicity.These drugs are considered to be cost-effective and are u...; 关键词：BIOLOGICS BIOSIMILARS cancer Escherichia coli monoclonal antibody next-generation sequencing PHARMACOVIGILANCE

Analytical Method Development and Validation of Some Biosimilar Drugs by High Performance Thin Layer Chromatography: 《American Journal of Analytical Chemistry》2023年第3期121-133,共13页Husna Kanwal Qureshi Ciddi Veeresham; A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica ge...; 关键词：BIOSIMILARS ETANERCEPT FILGRASTIM Method Development Validation

A phase III randomized,double-blind,placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk被引量：5: 《Acta Pharmacologica Sinica》2023年第2期446-453,共8页Hao Zhang Jie-mei Gu Ai-jun Chao Qun Cheng Dong-hui Teng Jin-ming Yu Bing-wu Wang Ya-nan Huo Li Mao Qiu Zhang Hong Yang Shi-gui Yan Ke-qin Zhang Xue-ling Zhao Hua Lin Yu Pei Zhong Yuan Ru-chun Dai Liang He Li Chen Yong-feng Su Zhong-liang Deng Li You Bo Ban Mei Zhu You-liang Cao Yi-kun Zhu Zhi-jun Li Zhi Zhang Cheng-qing Yi Yi-bing Lu Guang Wang Cui-cui Han Zhen-jiang Wang Xian-xing Li Zhen-lin Zhang; The current study evaluated the efficacy and safety of a denosumab biosimilar,QL1206(60 mg),compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk.At 31 study centers in China,a t...; 关键词：denosumab biosimilar postmenopausal osteoporosis Chinese women bone mineral density bone turnover markers adverse events

国内外生物类似药发展的立法比较与启示被引量：2: 《中国卫生资源》2022年第6期677-681,共5页王月强; 概述美国、欧盟、日本、韩国、中国等国家和地区在生物类似药物发展的立法现状,运用比较分析的方法,对比上述国家和地区在生物类似药发展的关键环节中的立法共性和差异,初步论证我国生物类似药发展的立法必要性,探讨国内生物类似药立法...; 关键词：生物类似药biosimilar 国际立法比较comparison of international legislation 法律启示legal implication

基于研发和生产视角的生物类似药特点分析: 《中国卫生资源》2022年第6期682-687,共6页刘升波艾丽静艾现伟车立平曹平刘传磊安振明; 生物类似药近年来得到快速发展,其研发和上市极大地降低了患者使用负担,提高了生物药的可及性。由于生物大分子本身内在的复杂结构和理化特点,生产工艺上的微小区别都可能使生物类似药与参照药间产生安全性、有效性的差异。生物类似药...; 关键词：生物类似药biosimilar 研发development 生产manufacture 相似性评价similarity evaluation

利益相关者视角下生物类似药互换使用国际经验借鉴与启示被引量：1: 《中国卫生资源》2022年第6期688-694,共7页丁丽曼吴晶; 选取美国和欧盟生物类似药监管历程作为研究对象,搭建利益相关者框架分析美国和欧盟在生物类似药互换使用管理过程中的职责分配与激励机制。美国和欧盟药品管理部门均建立了推动生物类似药可互换使用体系,并将可互换决定权限下放。美国...; 关键词：生物类似药biosimilar 可互换性interchangeability 利益相关者stakeholder 激励机制incentive mechanism

抗肿瘤生物类似药临床互换用药有效性与安全性的系统评价被引量：2: 《中国卫生资源》2022年第6期695-700,709,共7页胡杨宋再伟姜丹赵荣生; 国家自然科学基金(72074005)。; 目的系统评价抗肿瘤生物类似药临床互换用药的有效性、安全性与免疫原性,为促进其临床合理应用提供循证医学证据。方法系统检索PubMed、Embase、Cochrane Library、中国知网(CNKI)、万方数据库(WANFANG)、中国生物医学文献数据库(SinoM...; 关键词：生物类似药biosimilar 抗肿瘤antineoplastic 互换用药switching 可互换性interchangeability 有效性efficacy 安全性safety 免疫原性immunogenicity

BIOSIMILAR