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Ten years of clinical experience with biosimilar human growth hormone: a review of safety data
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
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2017 (English)In: Drug Design, Development and Therapy, ISSN 1177-8881, E-ISSN 1177-8881, Vol. 11, 1497-1503 p.Article, review/survey (Refereed) Published
Abstract [en]

Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope (R) (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin (R)). Additional concerns that may exist in relation to biosimilar rhGH include safety in indications granted on the basis of extrapolation and the impact of changing to biosimilar rhGH from other rhGH treatments. A substantial data set is available to fully understand the safety profile of biosimilar rhGH, which includes data from its clinical development studies and 10 years of post-approval experience. As of June 2016, 106,941,419 patient days (292,790 patient-years) experience has been gathered for biosimilar rhGH. Based on the available data, there have been no unexpected or unique adverse events related to biosimilar rhGH treatment. There is no increased risk of cancer, adverse glucose homeostasis, or immunogenic response with biosimilar rhGH compared with the reference medicine and other rhGH products. The immunogenicity of biosimilar rhGH is also similar to that of the reference and other rhGH products. Physicians should be reassured that rhGH products have a good safety record when used for approved indications and at recommended doses, and that the safety profile of biosimilar rhGH is in keeping with that of other rhGH products.

Place, publisher, year, edition, pages
Dove Press Ltd , 2017. Vol. 11, 1497-1503 p.
Keyword [en]
recombinant human growth hormone, Omnitrope (R), biosimilar
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:umu:diva-135986DOI: 10.2147/DDDT.S130909ISI: 000401843200003OAI: oai:DiVA.org:umu-135986DiVA: diva2:1109542
Available from: 2017-06-14 Created: 2017-06-14 Last updated: 2017-06-14Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
  • harvard1
  • ieee
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  • vancouver
  • Other style
More styles
Language
  • de-DE
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  • en-US
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  • nn-NB
  • sv-SE
  • Other locale
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