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

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

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
Soheilipour F¹²
Dalili S¹³
Kharazmi H¹⁴
Didban A¹⁵
Akhlaghi A¹⁶
Ghaznavi S²
Shahbazi M^{2, 4}

Show Affiliations

1. Neonatal and Children's Health Research Center, Golestan University of Medical Sciences, Gorgan, Iran
2. Department of Pediatric Endocrinology, AryaTinaGene Biopharmaceutical Company, Gorgan, Iran
3. Department of Hematology and Cell Therapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
4. Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran
5. Metabolic Liver Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
6. Pediatric Endocrinology Department, Akbar Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
7. Department of Pediatrics, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
8. Department of Pediatric, Tabriz University of Medical Sciences, Tabriz, Iran
9. Endocrinology and Metabolism Research Center, Institute of Basic and Clinical Physiology Science, Kerman University of Medical Sciences, Kerman, Iran
10. Department of Pediatric Endocrinology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
11. Department of Pediatric Endocrinology and Metabolism, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran
12. Pediatric Growth and Development Research Center, Institute of Endocrinology and Metabolism, Ali Asghar Children Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
13. Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran
14. Endocrinology and Metabolism Research Center, School of Medicine, Hormozgan University of Medical Sciences, Bandar Abas, Iran
15. Children Growth Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran
16. Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

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.

2. Growth Hormone Response to L-Arginine Alone and Combined With Different Doses of Growth Hormone-Releasing Hormone: A Systematic Review and Meta-Analysis, International Journal of Endocrinology (2022)

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Mahin Hashemipour (1)

Maryam Yazdi (1)

Style	Citing Format
MLA	Zaeri H, et al.. "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." Expert Opinion on Drug Safety, vol. 24, no. 1, 2025, pp. 111-119.
APA	Zaeri H, Omidvar S, Servatian N, Arefnia S, Khademolreza N, Amini H, Taghavi B, Hashemipour M, Eshraghi P, Ghasemi M, Ghergherehchi R, Maleki E, Moravej H, Noorian S, Soheilipour F, Dalili S, Kharazmi H, Didban A, Akhlaghi A, ... Shahbazi M (2025). 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. Expert Opinion on Drug Safety, 24(1), 111-119.
Chicago	Zaeri H, Omidvar S, Servatian N, Arefnia S, Khademolreza N, Amini H, Taghavi B, et al.. "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." Expert Opinion on Drug Safety 24, no. 1 (2025): 111-119.
Harvard	Zaeri H et al. (2025) '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', Expert Opinion on Drug Safety, 24(1), pp. 111-119.
Vancouver	Zaeri H, Omidvar S, Servatian N, Arefnia S, Khademolreza N, Amini H, et al.. 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. Expert Opinion on Drug Safety. 2025;24(1):111-119.
BibTex	@article{ author = {Zaeri H and Omidvar S and Servatian N and Arefnia S and Khademolreza N and Amini H and Taghavi B and Hashemipour M and Eshraghi P and Ghasemi M and Ghergherehchi R and Maleki E and Moravej H and Noorian S and Soheilipour F and Dalili S and Kharazmi H and Didban A and Akhlaghi A and Ghaznavi S and Shahbazi M}, title = {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}, journal = {Expert Opinion on Drug Safety}, volume = {24}, number = {1}, pages = {111-119}, year = {2025} }
RIS	TY - JOUR AU - Zaeri H AU - Omidvar S AU - Servatian N AU - Arefnia S AU - Khademolreza N AU - Amini H AU - Taghavi B AU - Hashemipour M AU - Eshraghi P AU - Ghasemi M AU - Ghergherehchi R AU - Maleki E AU - Moravej H AU - Noorian S AU - Soheilipour F AU - Dalili S AU - Kharazmi H AU - Didban A AU - Akhlaghi A AU - Ghaznavi S AU - Shahbazi M TI - 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 JO - Expert Opinion on Drug Safety VL - 24 IS - 1 SP - 111 EP - 119 PY - 2025 ER -

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