Expert Opinion on Biological Therapy, Volume 24, Issue 7 (2024)

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Expert Opinion on Biological Therapy, Volume 24, Issue 7 (2024)

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Volume 24, 2024 Vol 23, 2023 Vol 22, 2022 Vol 21, 2021 Vol 20, 2020 Vol 19, 2019 Vol 18, 2018 Vol 17, 2017 Vol 16, 2016 Vol 15, 2015 Vol 14, 2014 Vol 13, 2013 Vol 12, 2012 Vol 11, 2011 Vol 10, 2010 Vol 9, 2009 Vol 8, 2008 Vol 7, 2007 Vol 6, 2006 Vol 5, 2005 Vol 4, 2004 Vol 3, 2003 Vol 2, 2002 Vol 1, 2001
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Biosimilars 2024

Editorial

Editorial
Examining the impact of biosimilar-to-biosimilar transition on effectiveness and safety
Anan S. Jarab, Shrouq R. Abu Heshmeh & Ahmad Z. Al Meslamani
Pages: 563-566
Published online: 28 Feb 2024
First Page PreviewforExamining the impact of biosimilar-to-biosimilar transition on effectiveness and safety | Full Text | References | PDF (166.7 KB) | EPUB
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Free Access

Special Report

Report
Short and long-term economic implications of biosimilars
Ahmad Z. Al Meslamani
Pages: 567-570
Published online: 19 Jan 2024
AbstractforShort and long-term economic implications of biosimilars | Full Text | References | PDF (195.1 KB) | EPUB
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Perspective

Comment
Streamlining biosimilar development based on 20 years’ experience
Cecil Nick
Pages: 571-581
Published online: 22 Feb 2024
AbstractforStreamlining biosimilar development based on 20 years’ experience | Full Text | References | PDF (501.1 KB) | EPUB
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Review

Review Article
Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market
Isabel Río-Álvarez & Encarnación Cruz-Martos
Pages: 583-597
Published online: 06 Jun 2024
AbstractforOverview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market | Full Text | References | PDF (1.7 MB) | EPUB
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Review Article
Non-TNF biologics and their biosimilars in rheumatoid arthritis
Tsz Ching Mok & Chi Chiu Mok
Pages: 599-613
Published online: 22 May 2024
AbstractforNon-TNF biologics and their biosimilars in rheumatoid arthritis | Full Text | References | PDF (413.2 KB) | EPUB
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Review Article
Infliximab biosimilar GP1111: a review of 5 years’ post-approval experience
Thomas W. J. Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn & Claudio Romano
Pages: 615-625
Published online: 27 Jul 2024
AbstractforInfliximab biosimilar GP1111: a review of 5 years’ post-approval experience | Full Text | References | PDF (406.6 KB) | EPUB
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Open Access

Original Research

Article
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis
Heather Rae Hufnagel & Scott D Tennyson
Pages: 627-635
Published online: 04 Jul 2024
AbstractforIndustry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis | Full Text | References | PDF (769.4 KB) | EPUB | Supplemental
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Open Access
Article
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan
Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu & Yasuhiro Kishioka
Pages: 637-645
Published online: 09 Jul 2024
AbstractforRevisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan | Full Text | References | PDF (254.5 KB) | EPUB
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Article
Biosimilars and access to biologic therapy in immune-mediated diseases
Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri & Eva Negro-Vega
Pages: 647-653
Published online: 14 May 2024
AbstractforBiosimilars and access to biologic therapy in immune-mediated diseases | Full Text | References | PDF (609.1 KB) | EPUB
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Article
A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males
Anhye Kim, Jang Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin-Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee & Stuart Silverman
Pages: 655-663
Published online: 22 Feb 2024
AbstractforA randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males | Full Text | References | PDF (859.4 KB) | EPUB | Supplemental
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Open Access
Article
Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis
Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu & Weibo Xia
Pages: 665-672
Published online: 16 May 2024
AbstractforRandomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis | Full Text | References | PDF (1.8 MB) | EPUB
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Article
Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF)
Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl & Dorothy McCabe
Pages: 673-679
Published online: 19 May 2024
AbstractforRelative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF) | Full Text | References | PDF (302.5 KB) | EPUB
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Open Access
Article
Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study
Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, MinKyu Park, JunGi Hwang, Seol Ju Moon, Min-Gul Kim, Edward Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee & Gerd R Burmester
Pages: 681-689
Published online: 21 Jun 2024
AbstractforPharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study | Full Text | References | PDF (319.1 KB) | EPUB | Supplemental
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Open Access

Review

Review Article
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease
Gary R. Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh & Brian G. Feagan
Pages: 691-708
Published online: 18 Jul 2024
AbstractforSystematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease | Full Text | References | PDF (499.5 KB) | EPUB | Supplemental
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