Biosimilars, Volume 5, Issue (2015)

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Biosimilars, Volume 5, Issue (2015)

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Original Research

Article
Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197
Sanjay Bandyopadhyay, Mukesh Mahajan, Tulsi Mehta, Arun K Singh, Aashini Parikh, Ajit K Gupta, Pankaj Kalita, Mihir Patel & Sanjeev Kumar Mendiratta
Pages: 1-18
Published online: 31 Dec 2014
AbstractforPhysicochemical and functional characterization of a biosimilar adalimumab ZRC-3197 | Full Text | References | PDF (2.9 MB)
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Review

Review Article
Global regulatory landscape of biosimilars: emerging and established market perspectives
Anita Krishnan, Rustom Mody & Hemant Malhotra
Pages: 19-32
Published online: 17 Feb 2015
AbstractforGlobal regulatory landscape of biosimilars: emerging and established market perspectives | Full Text | References | PDF (440.9 KB)
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Perspectives

Challenging issues in assessing analytical similarity in biosimilar studies
Shein-Chung Chow
Pages: 33-39
Published online: 22 May 2015
AbstractforChallenging issues in assessing analytical similarity in biosimilar studies | Full Text | References | PDF (316.5 KB)
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Review

Review Article
Establishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data
Brian Bressler & Theo Dingermann
Pages: 41-48
Published online: 01 Jun 2015
AbstractforEstablishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data | Full Text | References | PDF (238.5 KB)
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Open Access
Review Article
Clinical trials in the development of biosimilars: future considerations
Brenda J Huneycutt, Earl Gillespie & Gillian R Woollett
Pages: 49-63
Published online: 09 Jul 2015
AbstractforClinical trials in the development of biosimilars: future considerations | Full Text | References | PDF (479.2 KB)
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Review Article
Clinical efficacy and safety of biosimilar epoetin: focus on epoetin zeta
Ashraf Mikhail & Christopher Brown
Pages: 65-73
Published online: 09 Sep 2015
AbstractforClinical efficacy and safety of biosimilar epoetin: focus on epoetin zeta | Full Text | References | PDF (262 KB)
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Original Research

Article
Low immunogenicity but reduced bioavailability of an interferon beta-1a biosimilar compared with its biological parent: results of MATRIX, a cross-sectional, multicenter phase 4 study
Carlos Cuevas, Florian Deisenhammer, Xiaojun You, Mariano Scolnik, Regine Buffels, Bjørn Sperling, Francisco Flores-Ramírez, Miguel Macías-Islas, Sergio Sauri-Suárez & On behalf of the MATRIX Investigator Group
Pages: 75-81
Published online: 15 Sep 2015
AbstractforLow immunogenicity but reduced bioavailability of an interferon beta-1a biosimilar compared with its biological parent: results of MATRIX, a cross-sectional, multicenter phase 4 study | Full Text | References | PDF (276.2 KB)
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Open Access

Methodology

Label-free interaction analysis as a tool to demonstrate biosimilarity of therapeutic monoclonal antibodies
Uma Sinha-Datta Srijit Khan & Dhananjay Wadgaonkar
Pages: 83-91
Published online: 16 Sep 2015
AbstractforLabel-free interaction analysis as a tool to demonstrate biosimilarity of therapeutic monoclonal antibodies | Full Text | References | PDF (2.9 MB)
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Original Research

Article
Pharmacokinetic and pharmacodynamic properties of a new biosimilar filgrastim TPI G-CSF in comparison to the marketed reference filgrastim Neupogen®: a double-blind, single-dose, two-period crossover trial
Sarfaraz K Niazi
Pages: 93-101
Published online: 03 Nov 2015
AbstractforPharmacokinetic and pharmacodynamic properties of a new biosimilar filgrastim TPI G-CSF in comparison to the marketed reference filgrastim Neupogen®: a double-blind, single-dose, two-period crossover trial | Full Text | References | PDF (581 KB)
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