Efficacy and safety of biosimilar growth hormone in Indian children

Abstract

Objective: To study efficacy and safety of use of biosimilar growth hormone (GH) in Indian children with growth disorders. Materials and Methods: We studied 322 children (May 2012-2017) with growth disorders including growth hormone deficiency (GHD), multiple pituitary hormone deficiency (MPHD, idiopathic short stature (ISS), small for gestational age (SGA), and Turner syndrome (TS). Children were treated either with innovator molecule (Norditropin) or biosimilar GH (Headon) with standard dosage protocol for 1 year. Height and weight was measured using standard protocol. Height and BMI for age Z-scores (HAZ, BMIZ), height velocity (HV), and HV Z-score (HVZ) were computed from available data. Results: Mean age of the studied children (n = 322) was 9.6 ± 4.1 years, 32% children had GHD, 39% had ISS, 11% had MPHD, 12% had SGA, and 6% children had TS. There were no serious adverse events; three patients recorded eight instances of headaches, two had rash at injection site, and one each had hives and facial edema. Reactions were mild and were treated symptomatically. At the end of the 1 year of GH therapy, change in HAZ was similar in children from both the innovator and biosimilar GH groups. Similarly, the HV and HVZ were also similar in children from both groups and all the studied growth disorders. Conclusion: Biosimilar GH was effective and safe for treatment in children with growth disorders where GH use is indicated. However, in the view of scarcity of such data a longitudinal study with large sample size is warranted.