TY - JOUR T1 - Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice JO - Anales de Pediatría (English Edition) T2 - AU - López-Siguero,Juan Pedro AU - Palla García,Margarida AU - Martínez Busto,Elena AU - Rebollo,Francisco José AU - Pombo,Manuel SN - 23412879 M3 - 10.1016/j.anpede.2017.03.021 DO - 10.1016/j.anpede.2017.03.021 UR - https://analesdepediatria.org/en-ten-years-experience-with-first-articulo-S2341287918300267 AB - IntroductionRecombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. Materials and methodsThis review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. ResultsThe equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. ConclusionThe number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug. ER -