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Drug Design, Development and Therapy Volume 11, 2017 - Issue
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Review

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data

Maria Victoria Borrás Pérez1 Hospital General de Granollers, Granollers, Barcelona, Spain
,
Berit Kriström2 Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden
,
Tomasz Romer3 Department of Endocrinology, Children’s Health Research Institute, Warsaw
,
Mieczyslaw Walczak4 Department of Paediatric Endocrinology and Diabetology, Pomeranian Medical University, Szczecin, Poland
,
Nadja Höbel5 Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, Germany
&
Markus Zabransky5 Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, GermanyCorrespondence[email protected]
Pages 1497-1503 | Published online: 16 May 2017

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Gianluca Trifirò, Ilaria Marcianò & Ylenia Ingrasciotta. (2018) Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence. Expert Opinion on Biological Therapy 18:3, pages 309-315.
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Paul Saenger. (2017) Ten years of biosimilar recombinant human growth hormone in Europe. Drug Design, Development and Therapy 11, pages 1505-1507.
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Articles from other publishers (10)

Fengping Sun, Liqin Chao, Junxia Zhang & Xiaoli Pan. (2023) Exercise combined with lysine-inositol vitamin B12 promotes height growth in children with idiopathic short stature. Growth Hormone & IGF Research, pages 101535.
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Alexander Römmler. 2022. Präventionsmedizin und Anti-Aging-Medizin. Präventionsmedizin und Anti-Aging-Medizin 141 166 .
Philippe Backeljauw, Bradley S. Miller, Richard Levy, Kenneth McCormick, Hichem Zouater, Markus Zabransky & Kim Campbell. (2021) PATRO children, a multi-center, non-interventional study of the safety and effectiveness of Omnitrope ® (somatropin) treatment in children: update on the United States cohort . Journal of Pediatric Endocrinology and Metabolism 34:4, pages 431-440.
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M.A. Czepielewski, Q. Garret, S.A.C. Vencio, N. Rassi, M.S. Faria, C.C.P. Senn, M.D. Bronstein, M.J.A.G. Cerqueira, A.C.L. Neves, A.M. Spinola-Castro, M.P.R. Cunha, N.R. Leite, G.E. Wassermann, M.C. Alegria, O. Toffoletto, J. Afiune, R. Baradelli, D.G. Rodrigues & M. Scharf. (2021) Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™): Results from a 6-month, multicentric, non-inferiority, extension trial.. Growth Hormone & IGF Research 56, pages 101372.
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M. Arosio, G. Arnaldi, V. Gasco, C. Giavoli, E. Puxeddu, R. Vettor, M. R. Ambrosio, P. Gallinari, H. Zouater, P. Fedeli & D. Ferone. (2020) Safety and effectiveness of Omnitrope® in patients with growth hormone deficiency: snapshot analysis of PATRO Adults study in the Italian population. Journal of Endocrinological Investigation 44:2, pages 327-337.
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Elena Lundberg, Berit Kriström, Hichem Zouater, Anna Deleskog & Charlotte Höybye. (2020) Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies. BMC Endocrine Disorders 20:1.
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Efraín Esteban, Rosa-Helena Bustos, Julio-César García & Edwin Jáuregui. (2019) Biosimilars: An Approach to some Current Worldwide Regulation Frameworks. Current Clinical Pharmacology 14:1, pages 16-40.
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Piotr Wiland, Bogdan Batko, Marek Brzosko, Eugeniusz Kucharz, Włodzimierz Samborski, Jerzy Świerkot, Ewa Więsik-Szewczyk & Julia Feldman. (2018) Biosimilar switching – current state of knowledge. Rheumatology 56:4, pages 234-242.
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Amulya Tatachar, Sidhartha D. Ray & Caitlin M. Gibson. 2018. A Worldwide Yearly Survey of New Data in Adverse Drug Reactions. A Worldwide Yearly Survey of New Data in Adverse Drug Reactions 521 526 .
Rikke Hjortebjerg, Gerhard Baumann & John J. Kopchick. 2017. Encyclopedia of Endocrine Diseases. Encyclopedia of Endocrine Diseases 116 126 .

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