Evaluation of the Safety and Efficacy of Biosimilar Recombinant Growth Hormone in Children With Growth Hormone Deficiency: Non-Inferiority, Randomized, Parallel, Multicentric and Phase Iii Trial Publisher Pubmed



Zaeri H¹ ; Omidvar S² ; Servatian N^{2, 3} ; Arefnia S¹ ; Khademolreza N² ; Amini H^{2, 4} ; Taghavi B² ; Hashemipour M⁵ ; Eshraghi P⁶ ; Ghasemi M⁷ ; Ghergherehchi R⁸ ; Maleki E⁹ ; Moravej H¹⁰ ; Noorian S¹¹ Show All Authors
Source: Expert Opinion on Drug Safety Published:2025

Abstract

Objectives: This study is designed in order to compare the efficacy and safety of recombinant human growth hormone (rhGH) with the reference brand. Methods: According to the inclusion criteria, 85 people in 13 Iranian centers were randomly selected to receive biosimilar Somatropin (Somatin®) (44 people) and reference Somatropin (Norditropin®) (41 people) at a dose of 35 µg/kg/d, seven days/week for 12 months. The primary outcomes included height velocity (HV) was measured during 12 months of treatment. Results: The two intervention groups’ Height changes were similar. The mean HV was 10.96 cm/year in the biosimilar group and 10.05 cm/year in the reference groups after 12 months. Estimates of the lower bounds of 95% CI for mean height differences in the biosimilar intervention group compared to the reference intervention group did not exceed the 2 cm margin. Therefore, the non-inferiority of biosimilar intervention compared to the brand product is verified. Common ADRs in both groups were nausea in two patients (2.4%), diarrhea in two patients (2.4%), increased body temperature in one patient (1.2%), and headache in one patient (1.2%). Conclusions: The finding of this study indicated that Somatin® and Norditropin® have comparable efficacy and safety profiles. Clinical trial registration: www.IRCT.irIRCT20171122037571N1. © 2024 Informa UK Limited, trading as Taylor & Francis Group.