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Efficacy and Safety of Biosimilar Growth Hormone in Indian Children

Vaman Khadilkar1, Veena Ekbote1, Anuradha Khadilkar1

  • 1Growth and Endocrine Department, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.

Indian Journal of Endocrinology and Metabolism
|August 28, 2018
PubMed

Insights

Biosimilar growth hormone (GH) is effective and safe for treating growth disorders in Indian children. The study found similar outcomes between biosimilar GH and innovator treatments, with no serious adverse events.

Area of Science:

  • Pediatric Endocrinology
  • Biotechnology
  • Pharmacology

Background:

  • Growth disorders in children require effective treatment options.
  • Biosimilar growth hormone (GH) offers a potential alternative to innovator therapies.
  • Understanding the efficacy and safety of biosimilar GH in diverse pediatric populations is crucial.

Purpose of the Study:

  • To evaluate the efficacy and safety of biosimilar GH (Headon) compared to innovator GH (Norditropin) in Indian children.
  • To assess treatment outcomes in various growth disorders including GHD, ISS, SGA, MPHD, and TS.
  • To provide data on biosimilar GH use in a pediatric population.

Main Methods:

  • A cohort of 322 Indian children with growth disorders were treated with either innovator or biosimilar GH for one year.
  • Standard dosage protocols were followed, and height and weight were measured regularly.
  • Height and BMI for age Z-scores (HAZ, BMIZ), height velocity (HV), and HV Z-score (HVZ) were calculated.

Main Results:

  • No serious adverse events were reported; mild side effects like headaches and injection site reactions occurred infrequently.
  • Children treated with biosimilar GH showed similar improvements in HAZ, HV, and HVZ compared to those on innovator GH.
  • Efficacy and safety were consistent across different growth disorders studied.

Conclusions:

  • Biosimilar GH is an effective and safe treatment option for children with indicated growth disorders.
  • Further large-scale, longitudinal studies are recommended to confirm these findings.
  • This study contributes valuable data on biosimilar GH use in pediatric patients.
Abstract

Keywords:
Biosimilar GHIndian childrenefficacy of GHgrowth disordersgrowth hormone

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