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Updated: Jun 18, 2026
11:17
Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Current status of biosimilar growth hormone
1Albert Einstein College of Medicine, Bronx, NY 10467, USA.
International Journal of Pediatric Endocrinology
|December 4, 2009
Summary
Biosimilar growth hormone demonstrates favorable efficacy and safety in pediatric patients, meeting regulatory standards in both Europe and the US. Further studies will assess its use in non-growth hormone deficiency conditions.
Area of Science:
- Biopharmaceuticals and biosimilars
- Endocrinology
- Pediatric growth disorders
Background:
- The expiration of biopharmaceutical patents necessitates the development of biosimilars, also known as follow-on protein products (FOPPs).
- Regulatory frameworks for biosimilars are more established in Europe than in the United States.
- The recent approval of biosimilar Somatropin (growth hormone) in both regions serves as a key case study.
Purpose of the Study:
- To review the scientific viability of biosimilar growth hormone.
- To evaluate the efficacy and safety data of biosimilar growth hormone compared to reference products.
Main Methods:
- Review of scientific literature and regulatory data for biosimilar Somatropin.
- Analysis of efficacy and safety data, including growth rates and IGF-1 generation.
- Comparison of data for pediatric indications with established growth hormones.
Main Results:
- Biosimilar growth hormone shows comparable efficacy and safety profiles to reference growth hormones over up to 7 years in pediatric indications.
- Data on growth rates and IGF-1 generation support the scientific viability of biosimilar growth hormone.
- US approval is currently limited to growth hormone deficiency (GHD) in children and adults.
Conclusions:
- Biosimilar growth hormone is scientifically viable and demonstrates favorable outcomes in pediatric GHD.
- The established regulatory pathways in Europe and the US facilitate biosimilar approvals.
- Future commercial use will enable comprehensive assessment of biosimilar growth hormone in non-GHD states.
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