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Review

Ten years’ clinical experience with biosimilar human growth hormone: a review of efficacy data

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Pages 1489-1495 | Published online: 16 May 2017

References

  • Omnitrope® Summary of Product Characteristics Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000607/WC500043695.pdfAccessed January 26, 2016
  • Consensus guidelines for the diagnosis and treatment of adults with growth hormone deficiency: summary statement of the Growth Hormone Research Society Workshop on Adult Growth Hormone DeficiencyJ Clin Endocrinol Metab1998832 379 3819467545
  • PfäffleRHormone replacement therapy in children: the use of growth hormone and IGF-IBest Pract Res Clin Endocrinol Metab2015293 339 35226051295
  • RomerTPeterFSaengerEfficacy and safety of a new ready-to-use recombinant human growth hormone solutionJ Endocrinol Invest2007307 578 58917848841
  • RomerTSaengerPPeterFSeven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III studyHorm Res2009726 359 36919844125
  • PeterFRomerTKoehlerB4 years of treatment with the rhGH Omnitrope® 5 mg/mL lyophilized formulation in growth hormone deficient children: efficacy and safety resultsPoster presented at: the LWPES/ESPE 8th Joint MeetingSeptember 9–12, 2009New York, NY
  • López-SigueroJBorrás PérezMVBalserSKhan-BolukiJLong-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III studyAdv Ther20112810 879 89321948492
  • Borrás PérezVLópez-SigueroJPMartínezGA follow-up study to monitor adult height among Spanish children with growth hormone deficiency who received biosimilar human recombinant growth hormone (Omnitrope®) during a phase III clinical trialAdv Ther2015322 148 15625667132
  • PfäffleRSchwabKOMargineanODesign of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope® in children requiring growth hormone treatmentTher Adv Endocrinol Metab201341 3 1123515245
  • PfäffleRKanumakalaSHöybyeCFour-year results from PATRO Children, a multi-centre, non-interventional study of the long-term safety and efficacy of Omnitrope® in children requiring growth hormone treatmentPoster presented at: the 55th Annual Meeting of the European Society for Paediatric EndocrinologySeptember 10–12, 2016Paris, France.
  • SchwarzHPBirkholz-WalerzakDSzaleckiMOne-year data from a long-term phase IV study of recombinant human growth hormone in short children born small for gestational ageBiol Ther201441–2 1 1324676989
  • SchwarzHPWalczakMBirkholz-WalerzakDTwo-year data from a long-term phase IV study of recombinant human growth hormone in short children born small for gestational ageAdv Ther2016333 423 43426886776
  • RomerTZabranskyMWalczakMSzaleckiMBalserSEffect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical dataBiol Ther20111 524392295
  • RashidNSaengerPWuYLSwitching to Omnitrope® from other recombinant human growth hormone therapies: a retrospective study in an integrated healthcare systemBiol Ther201441–2 27 3925096555