As the first wave of biopharmaceuticals is set to expire, biosimilars or follow-on protein products (FOPPs) have emerged. The\r\nregulatory foundation for these products is more advanced and better codified in Europe than in the US. Recent approval of\r\nbiosimilar Somatropin (growth hormone) in Europe and the US prompted this paper. The scientific viability of biosimilar growth\r\nhormone is reviewed. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 years for pediatric indications measure\r\nup favorably to previously approved growth hormones as reference comparators. While the approval in the US is currently only\r\nfor treatment of growth hormone deficiency (GHD) in children and adults, the commercial use of approved biosimilar growth\r\nhormones will allow in the future for in-depth estimation of their efficacy and safety in non-GH deficient states as well.
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