HGH (Human Growth Hormone)

Somatropin is the most extensively characterised substance in this range because it carries approved labelling in both the United States and the European Union. The European assessment of the first biosimilar compared it against the reference product in 89 growth-hormone-deficient children who had not been dosed before, measuring growth velocity over nine months, with both arms at about 10.7 cm per year. The approved labelling identifies the substance as a 191-amino-acid polypeptide of recombinant DNA origin, molecular weight 22,124 daltons, with a sequence identical to growth hormone of pituitary origin, produced in a modified strain of Escherichia coli. The warnings section of every approved product in the class is the reference safety profile for the whole growth hormone axis, covering neoplasm risk, glucose intolerance, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, slipped capital femoral epiphysis and pancreatitis.

What is not established

Nothing is established for any use outside the specific paediatric growth disturbances and adult growth hormone deficiency named in the approved labelling. Use in healthy adults for body composition, athletic performance or ageing is not an approved indication in either jurisdiction and is not supported by either label.

What distinguishes HGH (Human Growth Hormone)

Somatropin is the only substance in the growth hormone group here that is a protein rather than a peptide: 191 amino acids and 22,124 daltons, against five residues for ipamorelin and six for each growth hormone releasing peptide. That size is why it is regulated as a biologic, and why fourteen somatropin applications were statutorily converted from new drug applications into biologics licence applications on 23 March 2020, moving the class onto the biosimilar pathway. It is also the only one that acts directly at the growth hormone receptor; the secretagogues act upstream at the ghrelin receptor and IGF-1 LR3 acts downstream.

Sources

1. US FDA. List of approved NDAs for biological products deemed to be BLAs on 23 March 2020
2. US FDA. GENOTROPIN (somatropin) prescribing information, application 020280
3. European Medicines Agency. Omnitrope, EPAR, EMEA/H/C/000607, authorised 12 April 2006
4. World Anti-Doping Agency. 2026 Prohibited List, section S2.2.3
5. DailyMed, US National Library of Medicine. Current somatropin product labelling

This page describes a compound as a material and summarises published research about it. It is for general and procurement information only. It is not medical advice, not a treatment recommendation, and not guidance on use. Supplied for laboratory and research use, not for human consumption.