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Expert Opinion on Biological Therapy Volume 16, 2016 - Issue 10
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Original Research

Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®)

Hans-Peter HofmannPreclinical Development, Sandoz Biopharmaceuticals/Hexal AG, Holzkirchen, GermanyView further author information
,
Ulrich KronthalerPreclinical Development, Sandoz Biopharmaceuticals/Hexal AG, Holzkirchen, GermanyView further author information
,
Cornelius FritschExternal Bioassay Support, Novartis Pharma AG, Basel, SwitzerlandView further author information
,
Roger GrauExternal Bioassay Support, Novartis Pharma AG, Basel, SwitzerlandView further author information
,
Stefan O. MüllerSandoz Biopharmaceuticals/Hexal AG, Holzkirchen, GermanyView further author information
,
Robert MayerPhys. Chem. Characterization, Sandoz GmbH, Langkampfen, AustriaView further author information
,
Andreas SeidlGlobal Analyt Charact. & Bioanalyt., Hexal AG Oberhaching, Bayern, GermanyView further author information
&
Antonio Da SilvaPreclinical Development, Sandoz Biopharmaceuticals/Hexal AG, Holzkirchen, GermanyCorrespondence[email protected]
View further author information
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Pages 1185-1195 | Received 24 Jun 2016, Accepted 22 Jul 2016, Published online: 16 Aug 2016

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Christian Agboton & Joseph Salameh. (2022) Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe. Expert Opinion on Biological Therapy 22:2, pages 157-167.
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Lluís Puig & Anna López-Ferrer. (2019) Biosimilars for the treatment of psoriasis. Expert Opinion on Biological Therapy 19:10, pages 993-1000.
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John Fitton, Alessandro Giollo & Maya H. Buch. (2018) GP2015 as a promising therapy for rheumatoid arthritis. Expert Opinion on Biological Therapy 18:4, pages 477-481.
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Vibeke Strand, Giampiero Girolomoni, Martin Schiestl, Robert Ernst Mayer, Hilke Friccius-Quecke & Mark McCamish. (2017) The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar. Current Medical Research and Opinion 33:6, pages 993-1003.
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Articles from other publishers (23)

Adrián Urbano, Judith Plaza, César Picado & Fernando de Mora. (2023) Combined analytical assays for the characterization of drugs binding to human IgE: Applicability to omalizumab-bearing biosimilar candidates assessment. Biomedicine & Pharmacotherapy 169, pages 115848.
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Ammar Almaaytah. (2023) A Review of the Non-clinical and Clinical Requirements for the performance of a comparability exercise for Bevacizumab biosimilars. Research Journal of Pharmacy and Technology, pages 3499-3506.
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Sarfaraz K. Niazi & Zamara Mariam. (2023) Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies. Biologics 3:2, pages 72-94.
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Maria Chiara Ditto, Simone Parisi, Rossella Talotta, Marta Priora, Richard Borrelli & Enrico Fusaro. 2022. Biosimilars. Biosimilars.
Rosanne W. Meijboom, Helga Gardarsdottir, Matthijs L. Becker, Saskia ten Wolde, Toine C. G. Egberts & Thijs J. Giezen. (2021) Incidence of and Reasons and Determinants Associated with Retransitioning from Biosimilar Etanercept to Originator Etanercept. BioDrugs 35:6, pages 765-772.
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Hui Xiong, Fengyan Luo, Pengfei Zhou & Jizu Yi. (2021) Development of a reporter gene method to measure the bioactivity of anti-CD38 × CD3 bispecific antibody. Antibody Therapeutics 4:4, pages 212-221.
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Bastiaan L. Duivelshof, Amarande Murisier, Julien Camperi, Szabolcs Fekete, Alain Beck, Davy Guillarme & Valentina D'Atri. (2020) Therapeutic Fc‐fusion proteins: Current analytical strategies. Journal of Separation Science 44:1, pages 35-62.
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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Arnold G. Vulto, Martijn R. van der Plas & Helga Gardarsdottir. (2020) Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review. European Journal of Pharmaceutical Sciences 154, pages 105501.
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Víctor Pérez Medina Martínez, Lilia Tierrablanca-Sánchez, Carlos E. Espinosa-de la Garza, Laura C. Juárez-Bayardo, Nelly Piña-Lara, Germán Gonzalez Santoyo & Néstor O. Pérez. (2020) Functional analysis of glycosylation in Etanercept: Effects over potency and stability. European Journal of Pharmaceutical Sciences 153, pages 105467.
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Sara Žigon-Branc, Ariana Barlič & Matjaž Jeras. 2020. Cytokines. Cytokines.
Lan Wang, Chuanfei Yu & Junzhi Wang. (2020) Development of reporter gene assays to determine the bioactivity of biopharmaceuticals. Biotechnology Advances 39, pages 107466.
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Alfonso Duenas-Gonzalez & Aurora Gonzalez-Fierro. (2019) Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico. Therapeutic Innovation & Regulatory Science, pages 216847901983901.
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Alan Menter, Bruce E. Strober, Daniel H. Kaplan, Dario Kivelevitch, Elizabeth Farley Prater, Benjamin Stoff, April W. Armstrong, Cody Connor, Kelly M. Cordoro, Dawn M.R. Davis, Boni E. Elewski, Joel M. Gelfand, Kenneth B. Gordon, Alice B. Gottlieb, Arthur Kavanaugh, Matthew Kiselica, Neil J. Korman, Daniela Kroshinsky, Mark Lebwohl, Craig L. Leonardi, Jason Lichten, Henry W. Lim, Nehal N. Mehta, Amy S. Paller, Sylvia L. Parra, Arun L. Pathy, Reena N. Rupani, Michael Siegel, Emily B. Wong, Jashin J. Wu, Vidhya Hariharan & Craig A. Elmets. (2019) Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology 80:4, pages 1029-1072.
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Valderilio Feijó Azevedo, Alejandra Babini, Carlo V. Caballero-Uribe, Gilberto Castañeda-Hernández, Cecilia Borlenghi & Heather E. Jones. (2019) Practical Guidance on Biosimilars, With a Focus on Latin America. JCR: Journal of Clinical Rheumatology 25:2, pages 91-100.
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Ramin Fazel, Yudong Guan, Behrouz Vaziri, Christoph Krisp, Laura Heikaus, Amirhossein Saadati, Siti Nurul Hidayah, Manasi Gaikwad & Hartmut Schlüter. (2019) Structural and In Vitro Functional Comparability Analysis of Altebrel™, a Proposed Etanercept Biosimilar: Focus on Primary Sequence and Glycosylation. Pharmaceuticals 12:1, pages 14.
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Edith González-González, Rosa Camacho-Sandoval, Alexis Jiménez-Uribe, Alejandra Montes-Luna, Ilselena Cortés-Paniagua, Jazmín Sánchez-Morales, Leslie Muñoz-García, Alejandra V. Tenorio-Calvo, Carlos A. López-Morales, Marco A. Velasco-Velázquez, Lenin Pavón, Sonia Mayra Pérez-Tapia & Emilio Medina-Rivero. (2019) Validation of an ADCC assay using human primary natural killer cells to evaluate biotherapeutic products bearing an Fc region. Journal of Immunological Methods 464, pages 87-94.
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Jonathan Kay, Monika M Schoels, Thomas Dörner, Paul Emery, Tore K Kvien, Josef S Smolen & Ferdinand C Breedveld. (2018) Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Annals of the Rheumatic Diseases 77:2, pages 165-174.
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Sascha Gerdes, Ulrich Mrowietz, Matthias Augustin, Ralph von Kiedrowski, Alexander Enk, Klaus Strömer, Michael P. Schön & Marc A. Radtke. (2018) Biosimilars in der Dermatologie - Theorie wird Realität. JDDG: Journal der Deutschen Dermatologischen Gesellschaft 16:2, pages 150-162.
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Sascha Gerdes, Ulrich Mrowietz, Matthias Augustin, Ralph von Kiedrowski, Alexander Enk, Klaus Strömer, Michael P. Schön & Marc A. Radtke. (2018) Biosimilars in Dermatology - theory becomes reality. JDDG: Journal der Deutschen Dermatologischen Gesellschaft 16:2, pages 150-160.
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Emma D. Deeks. (2017) GP2015: An Etanercept Biosimilar. BioDrugs 31:6, pages 555-558.
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Hendrik Schulze-Koops & Alla Skapenko. (2017) Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm. Rheumatology 56:suppl_4, pages iv30-iv48.
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C.E.M. GriffithsD. Thaçi, S. Gerdes, P. Arenberger, G. Pulka, K. Kingo, J. Weglowska, N. Hattebuhr, J. Poetzl, H. Woehling, G. Wuerth & M. Afonso. (2017) The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. British Journal of Dermatology 176:4, pages 928-938.
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Lucy Smithers. (2015) Will Biosimilars Change the Treatment Paradigm in Psoriasis?. EMJ Dermatology, pages 39-46.
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