López-Siguero, Juan PedroPfäffle, RolandChanson, PhilippeSzalecki, MieczyslawHöbel, NadjaZabransky, Markus2017-06-272017-06-272017-05-16López-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;11:14891177-8881 (Online)http://hdl.handle.net/10668/2720In 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.enRecombinant human growth hormoneOmnitrope®BiosimilarBiosimilares farmacéuticosNiñoEuropaOrganización de la financiaciónHormona de crecimiento humanaHumanosProteínas recombinantesResultado del tratamientoMedical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Products::Biosimilar PharmaceuticalsMedical Subject Headings::Persons::Persons::Age Groups::ChildMedical Subject Headings::Geographical Locations::Geographic Locations::EuropeMedical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Financing, OrganizedMedical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Pituitary Hormones::Pituitary Hormones, Anterior::Growth Hormone::Human Growth HormoneMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Recombinant ProteinsMedical 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 Outcomeresearch article28553079open access10.2147/DDDT.S130320PMC5439972