Expert Opinion on Biological Therapy, Volume 23, Issue 8 (2023)

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Expert Opinion on Biological Therapy, Volume 23, Issue 8 (2023)

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Biosimilars

Foreword

Editorial
Preparing for the third decade of biosimilars
Ivo Abraham
Pages: 651-652
Published online: 14 Sep 2023
CitationforPreparing for the third decade of biosimilars | Full Text | References | PDF (145 KB) | EPUB
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Free Access

Perspective

The economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries
Matthias Calamia & Ivo Abraham
Pages: 653-657
Published online: 18 Aug 2023
AbstractforThe economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries | Full Text | References | PDF (226.2 KB) | EPUB
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Biosimilars for the next decade in Latin America: a window of opportunity
Tomas Gabriel Bas
Pages: 659-669
Published online: 08 Aug 2023
AbstractforBiosimilars for the next decade in Latin America: a window of opportunity | Full Text | References | PDF (278.2 KB) | EPUB
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The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region
Nimer S Alkhatib, Shiraz Halloush & Ivo Abraham
Pages: 671-677
Published online: 26 Jul 2023
AbstractforThe status and preparation for the next decade of biosimilars in the Middle Eastern and North African region | Full Text | References | PDF (1.4 MB) | EPUB
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The landscape of biosimilars in Saudi Arabia: preparing for the next decade
Abdulaali R. Almutairi, Ali M. Al-Samil, Abdulaziz Alsayyari, Consuela Cheriece Yousef, Mansoor Ahmed Khan, Hani S. Alhamdan & Ahmed Al-Jedai
Pages: 679-688
Published online: 28 Jul 2023
AbstractforThe landscape of biosimilars in Saudi Arabia: preparing for the next decade | Full Text | References | PDF (1.8 MB) | EPUB
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Preparing for the next decade of anti-VEGF biosimilars for retinal diseases: a focus on South Asia
Ashish Sharma, Nilesh Kumar, Nikulaa Parachuri, Anat Loewenstein, Francesco Bandello & Baruch D Kuppermann
Pages: 689-692
Published online: 24 Jul 2023
AbstractforPreparing for the next decade of anti-VEGF biosimilars for retinal diseases: a focus on South Asia | Full Text | References | PDF (198.9 KB) | EPUB
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Article
Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective
Shashank R Joshi, Shivani Mittra, Praveen Raj, Viraj Ramesh Suvarna & Sandeep N Athalye
Pages: 693-704
Published online: 21 Aug 2022
AbstractforBiosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective | Full Text | References | PDF (2.1 MB) | EPUB
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Open Access

Original Research

Article
Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial
Yinhan Guo, Tingting Guo, Yujing Di, Wenyu Xu, Zhitian Hu, Yanfeng Xiao, Heze Yu & Jie Hou
Pages: 705-715
Published online: 09 Mar 2023
AbstractforPharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial | Full Text | References | PDF (1.7 MB) | EPUB | Supplemental
  • 196 Views
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Article
Comparing the pharmacokinetics, safety, and immunogenicity of HLX02 to US- and EU-approved trastuzumab in healthy Chinese male subjects: A Phase I, randomized, double-blind, parallel-group study
Wenjia Zhou, Meng Wang, Yunli Yu, Ji Wang, Yanni Wu, Guiyu Yang, Haoyu Yu, Jing Li, Liang Zhou & Quanying Zhang
Pages: 717-725
Published online: 26 Feb 2023
AbstractforComparing the pharmacokinetics, safety, and immunogenicity of HLX02 to US- and EU-approved trastuzumab in healthy Chinese male subjects: A Phase I, randomized, double-blind, parallel-group study | Full Text | References | PDF (487.4 KB) | EPUB | Supplemental
  • 93 Views
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Article
Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects
Qin Zhang, Cheng Sun, Jinying Wu, Juan Wu, Xuan Zhang, Yueyue Liu, Changlin Dou, Huilin Qin, Qian Zhang, Renpeng Zhou & Wei Hu
Pages: 727-735
Published online: 13 Mar 2023
AbstractforPharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects | Full Text | References | PDF (2.4 MB) | EPUB | Supplemental
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Article
A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea
Jae-Cheol Jo, Youngwoo Jeon, DaJung Kim, Deok-Hwan Yang, Won Sik Lee, Yoon Seok Choi, Jun Ho Yi, Dok Hyun Yoon, Jee Hyun Kong, Jung-Yoon Choe, SungHyun Kim, KeumYoung Ahn, TaeHong Park, Hana Ju, Soonbum Kwon & Seok-Goo Cho
Pages: 737-747
Published online: 08 Mar 2023
AbstractforA non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea | Full Text | References | PDF (354.6 KB) | EPUB | Supplemental
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Open Access
Article
GP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar
Oliver von Richter, Terry O’Reilly, Davide Guerrieri, Jamie Fan, Constanze Fey, Steven Schussler, Fabricio Furlan & Lena Lemke
Pages: 749-758
Published online: 30 Aug 2022
AbstractforGP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar | Full Text | References | PDF (743.5 KB) | EPUB | Supplemental
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Open Access
Article
Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis
Steven R Feldman, Nataliya Reznichenko, Fausto Berti, Paul Duijzings, Ruth Ruffieux, Hendrik Otto, Halimu N Haliduola, Steffen Leutz & Heimo Stroissnig
Pages: 759-771
Published online: 12 Jul 2023
AbstractforRandomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis | Full Text | References | PDF (2.2 MB) | EPUB | Supplemental
  • 1909 Views
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Open Access
Article
A multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults
Christopher Wynne, Christian Schwabe, Heimo Stroissnig, Roshan Dias, Joanna Sobierska, Eric Guenzi, Hendrik Otto, Abid Sattar, Halimu N Haliduola, Elin Edwald & Fausto Berti
Pages: 773-780
Published online: 05 Oct 2022
AbstractforA multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults | Full Text | References | PDF (591.9 KB) | EPUB | Supplemental
  • 1323 Views
  • 1 CrossRef citations
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Open Access
Article
Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe
Nemanja Damjanov, Nana Kirvalidze, Nana Kurashvili, Fausto Berti, Matjaz Steiger, Joanna Sobierska, Eric Guenzi, Hendrik Otto, Abid Sattar, Halimu N. Haliduola, Elin Edwald & Heimo Stroissnig
Pages: 781-789
Published online: 26 Oct 2022
AbstractforAssessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe | Full Text | References | PDF (678.6 KB) | EPUB | Supplemental
  • 1513 Views
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Open Access
Article
Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD)
Bernd Bokemeyer, Tibor Hlavaty, Matthieu Allez, Pamela Selema, Shahrzad Moosavi, Mary Jane Cadatal, Heather Fowler, Markus Mueller, Katherine F Liau & Javier P Gisbert
Pages: 791-800
Published online: 16 Apr 2023
AbstractforReal-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD) | Full Text | References | PDF (628 KB) | EPUB | Supplemental
  • 1153 Views
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Open Access
Article
Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance
Rosanne W Meijboom, Liese Barbier, Louise C Druedahl, Kati Sarnola, Hanna M Tolonen, Helga Gardarsdottir, Toine C G Egberts & Thijs J Giezen
Pages: 801-817
Published online: 23 Mar 2023
AbstractforRecommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance | Full Text | References | PDF (1.9 MB) | EPUB | Supplemental
  • 1312 Views
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Open Access
Article
Adalimumab originator versus adalimumab biosimilars in inflammatory bowel disease in Australia
Emilia Anderson, Karen Waller, Aravind Gokul Tamilarasan, Huiyu Lin, Sudarshan Paramsothy & Rupert W Leong
Pages: 819-825
Published online: 19 Apr 2023
AbstractforAdalimumab originator versus adalimumab biosimilars in inflammatory bowel disease in Australia | Full Text | References | PDF (441.5 KB) | EPUB
  • 245 Views
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Article
Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey
Patrícia Sarlós, Alexander Bikar, Nelli Farkas, Tamás Resál, Zoltán Szepes, Klaudia Farkas, Ferenc Nagy, Áron Vincze, Pal Miheller & Tamás Molnár
Pages: 827-832
Published online: 09 May 2023
AbstractforSelf-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey | Full Text | References | PDF (403.6 KB) | EPUB | Supplemental
  • 1510 Views
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Open Access
Article
Real-life data on efficacy and safety of original Adalimumab and biosimilar Adalimumab (ABP 501) in pediatric rheumatic diseases
Kadir Ulu, Mustafa Çakan, Şengül Çağlayan, Ramazan Emre Yiğit, Ferhat Demir, Taner Coşkuner, Esra Kardeş & Betül Sözeri
Pages: 833-839
Published online: 13 Sep 2022
AbstractforReal-life data on efficacy and safety of original Adalimumab and biosimilar Adalimumab (ABP 501) in pediatric rheumatic diseases | Full Text | References | PDF (590.6 KB) | EPUB
  • 216 Views
  • 2 CrossRef citations
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Article
Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States
Xiangzhong Xue, Bang Truong & Jingjing Qian
Pages: 841-849
Published online: 09 Mar 2023
AbstractforAdverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States | Full Text | References | PDF (519.3 KB) | EPUB | Supplemental
  • 129 Views
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Article
Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER – survey)
Ashish Sharma, Frank G Holz, Carl D Regillo, K Bailey Freund, David Sarraf, Arshad M. Khanani, Caroline Baumal, Nancy Holekamp, Ramin Tadayoni, Nilesh Kumar, Nikulaa Parachuri, Baruch D Kuppermann, International Retina Biosimilar Study Group (Inter BIOS Group)International Retina Biosimilar Study Group (Inter BIOS Group)Francesco Bandello, Giuseppe Querques, Anat Loewenstein, Şengül Özdek, Kourous Rezai, Kodjikian Laurent, Alper Bilgic, Paolo Lanzetta, Dinah Zur, Nicolas Yannuzzi, Giulia Corradetti, Peter Kaiser, Assaf Hilely, David Boyer, Aleksandra Rachitskaya, Usha Chakravarthy, Maximilian Wintergerst, Valentina Sarao, Barbara Parolini, Prithvi Mruthyunjaya, Quan Dong Nguyen, Diana DO, Pearse A Keane, Tarek Hassan, Jayanth Sridhar, David Eichenbaum, Dilraj Grewal & Martin Splitzer
Pages: 851-859
Published online: 19 Feb 2023
AbstractforBiosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER – survey) | Full Text | References | PDF (3.9 MB) | EPUB
  • 321 Views
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