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® (
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®). 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.