Expert Opinion on Biological Therapy, Volume 22, Issue 2 (2022)

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Expert Opinion on Biological Therapy, Volume 22, Issue 2 (2022)

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Biosimilars

Drug Evaluation

Article
Current evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM): a multidisciplinary perspective
Javier P. Gisbert, Karl Gaffney, David Young, Hans C. Ebbers & Giampiero Girolomoni
Pages: 109-121
Published online: 31 Dec 2021
AbstractforCurrent evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM): a multidisciplinary perspective | Full Text | References | PDF (1.2 MB) | EPUB
  • 2227 Views
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Open Access

Review

Review
Need for a risk-based control strategy for managing glycosylation profile for biosimilar products
Anurag Rathore & Himanshu Malani
Pages: 123-131
Published online: 01 Sep 2021
AbstractforNeed for a risk-based control strategy for managing glycosylation profile for biosimilar products | Full Text | References | PDF (1.6 MB) | EPUB | Supplemental
  • 279 Views
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Review
The global landscape on interchangeability of biosimilars
Anurag S. Rathore, James G. Stevenson, Hemlata Chhabra & Chinmoyee Maharana
Pages: 133-148
Published online: 06 May 2021
AbstractforThe global landscape on interchangeability of biosimilars | Full Text | References | PDF (2 MB) | EPUB | Supplemental
  • 695 Views
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Review
Biosimilars: A futuristic fast-to-market advice to developers
Sarfaraz K. Niazi
Pages: 149-155
Published online: 27 Dec 2021
AbstractforBiosimilars: A futuristic fast-to-market advice to developers | Full Text | References | PDF (300.4 KB) | EPUB
  • 250 Views
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Perspective

Article
Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe
Christian Agboton & Joseph Salameh
Pages: 157-167
Published online: 09 Aug 2021
AbstractforBiosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe | Full Text | References | PDF (492.9 KB) | EPUB
  • 302 Views
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Original Research

Article
A randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex®
Mika Scheinin, Zsófia Lovró, Inger-Helen Maadik, Jaana Suopanki-Lalowski, Seyed Hossein Seyedagha & Morteza Azhdarzadeh
Pages: 169-178
Published online: 08 Mar 2021
AbstractforA randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex® | Full Text | References | PDF (3.2 MB) | EPUB
  • 129 Views
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Article
Safety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese men
Hong Zhang, Ting Liu, Min Wu, Haijing Wei, Cuiyun Li, Xiaojiao Li, jingrui Liu, Hong Chen, Yanhua Ding & Li Liu
Pages: 179-186
Published online: 17 Mar 2021
AbstractforSafety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese men | Full Text | References | PDF (3.7 MB) | EPUB | Supplemental
  • 152 Views
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Article
A randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects
Guangwen Liu, Zhongnan Xu, Wei Yang, Jinling Xue, Yanli Wang, Zhengzhi Liu, Yingzi Cui, Xinyao Qu, Tianying Chang, Shuang Yu, Yang Cheng, Yannan Zhou, Jiahui Chen, Qing Ren, Wanhua Wang, Qiaohuan Deng, Zeyu Wang & Haimiao Yang
Pages: 187-195
Published online: 18 Oct 2021
AbstractforA randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects | Full Text | References | PDF (468 KB) | EPUB | Supplemental
  • 219 Views
  • 1 CrossRef citations
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Article
Toward the integration of biosimilars into pediatric rheumatology: adalimumab ABP 501 experience of PeRA research group
Fatma Gül Demirkan, Kadir Ulu, Kübra Öztürk, Şerife Gül Karadağ, Semanur Özdel, Hafize Emine Sönmez, Figen Çakmak, Ferhat Demir, Betül Sözeri & Nuray Aktay Ayaz
Pages: 197-202
Published online: 16 Nov 2021
AbstractforToward the integration of biosimilars into pediatric rheumatology: adalimumab ABP 501 experience of PeRA research group | Full Text | References | PDF (264.6 KB) | EPUB | Supplemental
  • 286 Views
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Article
A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence
Fabio Salvatore Macaluso, JR Fraser Cummings, Raja Atreya, Jaeyun Choi & Ambrogio Orlando
Pages: 203-223
Published online: 18 Feb 2022
AbstractforA Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence | Full Text | References | PDF (953.5 KB) | EPUB
  • 3778 Views
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Open Access
Article
A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers
Yanli Wang, Zhenyue Gao, Zhengzhi Liu, Guangwen Liu, Xinyao Qu, Jiahui Chen, Xinran Ren, Zhongnan Xu & Haimiao Yang
Pages: 225-234
Published online: 30 Jun 2021
AbstractforA randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers | Full Text | References | PDF (507.5 KB) | EPUB | Supplemental
  • 237 Views
  • 2 CrossRef citations
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Article
A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers
Ekaterina Raykova, Mohammad Farmahini Farahani, Stanislava Ivanova & Morteza Azhdarzadeh
Pages: 235-243
Published online: 25 Aug 2021
AbstractforA randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers | Full Text | References | PDF (1.4 MB) | EPUB
  • 109 Views
  • 1 CrossRef citations
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Article
Medical students’ knowledge and awareness levels about biologics and biosimilars: the earlier the better?
Devrim Demir-Dora & Zinnet Şevval Aksoyalp
Pages: 245-251
Published online: 27 Sep 2021
AbstractforMedical students’ knowledge and awareness levels about biologics and biosimilars: the earlier the better? | Full Text | References | PDF (283.8 KB) | EPUB
  • 124 Views
  • 3 CrossRef citations
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Article
Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial
Wenliang Dong, Min Chen, Suping Niu, Bianzhen Wang, Lin Xia, Jiaxue Wang, Tiantian Shen, Qian Wang, Jie Lv, Gang Liu, Huaying Fan, Zhenwei Xie, Fan Xie, Youzhong an, Qingshan Zheng, Huiying Rao, Haifeng Song & Yi Fang
Pages: 253-262
Published online: 26 Jul 2021
AbstractforPharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial | Full Text | References | PDF (1 MB) | EPUB | Supplemental
  • 254 Views
  • 2 CrossRef citations
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Article
A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects
Renpeng Zhou, Jingjing Yang, Yueyue Liu, Qian Zhang, Chao Lu, Ke Tang, Xiao Li, Wei Tang, Emei Gao, Can Wu, Changlin Dou & Wei Hu
Pages: 263-269
Published online: 27 Dec 2021
AbstractforA randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects | Full Text | References | PDF (815.1 KB) | EPUB
  • 147 Views
  • 1 CrossRef citations
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Article
Analytical similarity assessment of MYL-1402O to reference Bevacizumab
Parag Goyal, Bhavesh Vats, Malini Subbarao, Chethan Gejjalagere Honnappa, Pradeep Kabadi, Sheija Rohil, Arnab Bera, Gaurav R Mehta, Harish Pai, Laxmi Adhikari, Ranitendranath Tagore, Shulagna Sharma, Roopa Venkatachala, Pradip Nair, Shankara Annegowda, Abhilashi Sahu, Sneha Trivedi, Namrata Shastri, Yatika Gokhale, Roshni Thomas, Anushikha Thakur, Deepa Mohan, Umamaheshwara Rao K, Ramakrishnan Melarkode & Rajesh Ullanat
Pages: 271-298
Published online: 13 Oct 2021
AbstractforAnalytical similarity assessment of MYL-1402O to reference Bevacizumab | Full Text | References | PDF (11.9 MB) | EPUB
  • 227 Views
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Article
Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration
Bhavesh Vats, Parag Goyal, Zacharia Mathew, Ranendu Ghosh, Moram Narendra Babu, Rahul Singh Jadav, Arya M. Nair, Malini Subbarao, Arnab Bera, Kirthi Prakash Sadasivappa, Pradeep Kabadi, Anindya Sarkar, Chethan Gejjalagere Honnappa, Uma Sankar Patnaik, Ankita Singh, Anusha Valiya Parambath & Rajesh Ullanat
Pages: 299-311
Published online: 02 May 2021
AbstractforEvaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration | Full Text | References | PDF (3.7 MB) | EPUB | Supplemental
  • 176 Views
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Article
Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy
Antonio Tursi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo Forti, Federica Gaiani, Maria Giovanna Graziani, Roberto Lorenzetti, Francesco Luzza, Pietro Paese, Antonio Penna, Roberta Pica, Giuseppe Pranzo, Stefano Rodinò, Antonella Scarcelli, Costantino Zampaletta, Lorenzo Brozzi, Clelia Cicerone, Andrea Cocco, Gianluigi De’ Angelis, Laura Donnarumma, Serafina Fiorella, Chiara Iannelli, Tiziana Larussa, Marco Le Grazie, Ileana Luppino, Costantino Meucci, Roberto FaggianI, Cristiano Pagnini, Patrizia Perazzo, Kryssia Isabel Rodriguez-Castro, Rodolfo Sacco, Ladislava Sebkova, Mariaelena Serio, Alberta De Monti, Marcello Picchio, Daniele Napolitano, Elisa Schiavoni, Laura Turchini, Franco Scaldaferri, Daniela Pugliese, Luisa Guidi, Lucrezia Laterza, Giuseppe Privitera, Marco Pizzoferrato, Loris R. Lopetuso, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi & Alfredo Papa
Pages: 313-320
Published online: 27 Dec 2021
AbstractforComparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy | Full Text | References | PDF (496.7 KB) | EPUB
  • 300 Views
  • 1 CrossRef citations
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Article
A comparative multi-tiered immunogenicity assessment of biosimilar pegylated filgrastim: validation of methods for clinical assessment of INTP5
Pallavi Hajela, Ronak Patel, Prashant Kale, Manish Kumar & Sridevi Khambhampaty
Pages: 321-330
Published online: 18 Nov 2021
AbstractforA comparative multi-tiered immunogenicity assessment of biosimilar pegylated filgrastim: validation of methods for clinical assessment of INTP5 | Full Text | References | PDF (998.5 KB) | EPUB
  • 97 Views
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Article
Device Development for Biosimilars: Human Factor Engineering for a Teriparatide Pen
Ronak Patel, Pravin Nair, Meenal Bhatnagar, Sridevi Khambhampaty & Suresh Gupta
Pages: 331-343
Published online: 27 Dec 2021
AbstractforDevice Development for Biosimilars: Human Factor Engineering for a Teriparatide Pen | Full Text | References | PDF (1.5 MB) | EPUB
  • 317 Views
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