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Title: Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data
Authors: López-Siguero, Juan Pedro
Pfäffle, Roland
Chanson, Philippe
Szalecki, Mieczyslaw
Höbel, Nadja
Zabransky, Markus
metadata.dc.contributor.authoraffiliation: [López-Siguero,JP] Servicio de Endocrinología Pediátrica, Hospital Materno-Infantil, Hospital Regional Universitario de Málaga, Spain. [Pfäffle,R]University Children’s Hospital Leipzig, Germany. [Chanson,P] Department of Endocrinology and Reproductive Diseases, Hôpital de Bicêtre, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris and University Paris-Sud, Le Kremlin-Bicêtre, France. [Szalecki,M] Clinic of Endocrinology and Diabetology, Children’s Memorial Health Institute, Warsaw, Poland. Faculty of Medicine and Health Sciences UJK, Kielce, Poland. [Höbel,N; Zabransky,M] Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, Germany.
Keywords: Recombinant human growth hormone;Omnitrope®;Biosimilar;Biosimilares farmacéuticos;Niño;Europa;Organización de la financiación;Hormona de crecimiento humana;Humanos;Proteínas recombinantes;Resultado del tratamiento
metadata.dc.subject.mesh: Medical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Products::Biosimilar Pharmaceuticals
Medical Subject Headings::Persons::Persons::Age Groups::Child
Medical Subject Headings::Geographical Locations::Geographic Locations::Europe
Medical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Financing, Organized
Medical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Pituitary Hormones::Pituitary Hormones, Anterior::Growth Hormone::Human Growth Hormone
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Recombinant Proteins
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome
Issue Date: 16-May-2017
Publisher: Dove Medical Press
Citation: López-Siguero JP, Päffle R, Chanson P, Szalecki M, Höbel N, Zabransky M. Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data. Drug Des Devel Ther. 2017;11:1489
Abstract: In 2006, the European Medicines Agency (EMA) approved Omnitrope(®) as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®), Pfizer). Data continue to be collected on the long-term efficacy of biosimilar rhGH from several on-going postapproval studies. Particular topics of interest include efficacy in indications granted on the basis of extrapolation, and whether efficacy of growth hormone treatment is affected when patients are changed to biosimilar rhGH from other rhGH products. Data from clinical development studies and 10 years of postapproval experience affirm the clinical efficacy and effectiveness of biosimilar rhGH across all approved indications. In addition, the decade of experience with biosimilar rhGH since it was approved in Europe confirms the scientific validity of the biosimilar pathway and the approval process. Concerns about clinical effect in extrapolated indications, and also about the impact of changing from other rhGH preparations, have been alleviated. Biosimilar rhGH is an effective treatment option for children who require therapy with rhGH.
metadata.dc.identifier.doi: 10.2147/DDDT.S130320
ISSN: 1177-8881 (Online)
Appears in Collections:01- Artículos - Hospital Regional de Málaga

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