Borrás Pérez Maria Victoria, Kriström Berit, Romer Tomasz, Walczak Mieczyslaw, Höbel Nadja, Zabransky Markus
Hospital General de Granollers, Granollers, Barcelona, Spain.
Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Drug Des Devel Ther. 2017 May 16;11:1497-1503. doi: 10.2147/DDDT.S130909. eCollection 2017.
Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin). Additional concerns that may exist in relation to biosimilar rhGH include safety in indications granted on the basis of extrapolation and the impact of changing to biosimilar rhGH from other rhGH treatments. A substantial data set is available to fully understand the safety profile of biosimilar rhGH, which includes data from its clinical development studies and 10 years of post-approval experience. As of June 2016, 106,941,419 patient days (292,790 patient-years) experience has been gathered for biosimilar rhGH. Based on the available data, there have been no unexpected or unique adverse events related to biosimilar rhGH treatment. There is no increased risk of cancer, adverse glucose homeostasis, or immunogenic response with biosimilar rhGH compared with the reference medicine and other rhGH products. The immunogenicity of biosimilar rhGH is also similar to that of the reference and other rhGH products. Physicians should be reassured that rhGH products have a good safety record when used for approved indications and at recommended doses, and that the safety profile of biosimilar rhGH is in keeping with that of other rhGH products.
重组人生长激素（rhGH）治疗的安全性问题包括对癌症风险的影响、对葡萄糖稳态的影响以及对内源性/外源性生长激素抗体的形成。奥曲肽（生物类似物rhGH）于2006年获得欧洲药品管理局批准，批准依据是其质量、安全性和疗效与参比药品（健高素）相当。与生物类似物rhGH相关的其他潜在问题包括基于外推法获批适应症的安全性以及从其他rhGH治疗转换为生物类似物rhGH的影响。有大量数据集可用于全面了解生物类似物rhGH的安全性概况，其中包括其临床研发研究数据以及批准后10年的经验数据。截至2016年6月，已收集到生物类似物rhGH的106,941,419患者日（292,790患者年）的使用经验。根据现有数据，与生物类似物rhGH治疗相关的未出现意外或独特的不良事件。与参比药品和其他rhGH产品相比，生物类似物rhGH不存在癌症风险增加、葡萄糖稳态不良或免疫原性反应增加的情况。生物类似物rhGH的免疫原性也与参比药品和其他rhGH产品相似。医生应放心，rhGH产品在用于获批适应症并按推荐剂量使用时具有良好的安全记录，且生物类似物rhGH的安全性概况与其他rhGH产品一致。
