Axis Clinicals Latinamerica, Ingeniero Basiliso Romo Anguiano 225, Col. Guadalupe Insurgentes, Mexico City, 07870, Mexico.

Axis Clinicals Latinamerica, Ingeniero Basiliso Romo Anguiano 225, Col. Guadalupe Insurgentes, Mexico City, 07870, Mexico.

Laboratorios PiSA, Miguel Ángel de Quevedo 555, Col. Romero de Terreros, Mexico City, 04310, Mexico.
Biosimilars ,Biocomparability , r-hGH ,Pharmacokinetic ,Pharmacodynamic ,

Biosimilars are biological products that are the replica of their innovator biopharmaceuticals. Growth hormone is used to treat growth deficiency in children and another disorder. The objective of this study was to assess the relative pharmacokinetic and pharmacodynamics biocomparability of r-hGH biosimilar versus r-hGH reference. The study was performed in 23 healthy volunteers who underwent pituitary somatotrope cell down-regulation using octreotide, according to a randomized, two-period, and two sequence crossover design. Following subcutaneous administration of r-hGH (biosimilar or reference) pharmacokinetic and pharmacodynamics parameters were analyzed. Geometric mean values for AUC0-inf, AUC0-24 and t½ were similar between the two r-hHG and the 95% confidence interval, all within the specified acceptance range (80- 125%). There were no significative differences for IGF-I and IGFBP-III biomarkers, and also for the IGF-I/IGFBP-III molar ratio. Results demonstrate de biosimilarity of the r-hGH biosimilar with r-hGH reference in healthy volunteers

4 , 1 , 2014