RT Journal Article
T1 Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data
A1 López-Siguero, Juan Pedro
A1 Pfäffle, Roland
A1 Chanson, Philippe
A1 Szalecki, Mieczyslaw
A1 Höbel, Nadja
A1 Zabransky, Markus
K1 Recombinant human growth hormone
K1 Omnitrope®
K1 Biosimilar
K1 Biosimilares farmacéuticos
K1 Niño
K1 Europa
K1 Organización de la financiación
K1 Hormona de crecimiento humana
K1 Humanos
K1 Proteínas recombinantes
K1 Resultado del tratamiento
AB 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.
PB Dove Medical Press
SN 1177-8881 (Online)
YR 2017
FD 2017-05-16
LK http://hdl.handle.net/10668/2720
UL http://hdl.handle.net/10668/2720
LA en
NO 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
NO Funded by Sandoz GmbH
DS RISalud
RD Apr 6, 2025