Saenger Paul
Albert Einstein College of Medicine, Bronx, NY 10467, USA.
Int J Pediatr Endocrinol. 2009;2009:370329. doi: 10.1155/2009/370329. Epub 2009 Sep 29.
As the first wave of biopharmaceuticals is set to expire, biosimilars or follow-on protein products (FOPPs) have emerged. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Recent approval of biosimilar Somatropin (growth hormone) in Europe and the US prompted this paper. The scientific viability of biosimilar growth hormone is reviewed. Efficacy and safety data (growth rates, IGF-1 generation) for up to 7 years for pediatric indications measure up favorably to previously approved growth hormones as reference comparators. While the approval in the US is currently only for treatment of growth hormone deficiency (GHD) in children and adults, the commercial use of approved biosimilar growth hormones will allow in the future for in-depth estimation of their efficacy and safety in non-GH deficient states as well.
随着首批生物制药即将到期，生物类似药或后续蛋白产品（FOPPs）应运而生。相较于美国，欧洲针对这些产品的监管基础更为先进且编纂得更好。近期欧洲和美国批准了生物类似药生长激素（索马鲁肽），促使撰写本文。本文对生物类似生长激素的科学可行性进行了综述。针对儿科适应症长达7年的疗效和安全性数据（生长速率、IGF-1生成）与先前批准的生长激素作为参考对照相比表现良好。虽然目前美国的批准仅用于治疗儿童和成人的生长激素缺乏症（GHD），但获批的生物类似生长激素的商业使用未来也将有助于深入评估其在非生长激素缺乏状态下的疗效和安全性。
