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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
Keywords: Omnitrope®;biosimilar;recombinant human growth hormone
metadata.dc.subject.mesh: Biosimilar Pharmaceuticals
Drug Approval
Drug Design
Human Growth Hormone
Recombinant Proteins
Issue Date: 16-May-2017
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
Appears in Collections:Producción 2020

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