Patel Nayana Hitesh, Patel Niket H, Patel Molina Niket, Bhadarka Harsha K, Vyas Kairavi Sunilkumar
Department of Reproductive Medicine, Akanksha Hospital and Research Institute, Anand, Gujarat, India.
J Hum Reprod Sci. 2023 Apr-Jun;16(2):148-155. doi: 10.4103/jhrs.jhrs_37_23. Epub 2023 Jun 30.
Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug.
To compare the ART outcomes in patients receiving originator follitropin (Gonal-f) and its biosimilars in clinical setting.
Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed.
Participants were divided into two cohorts based on treatment (Gonal-f cohort; = 174 and biosimilar cohort; = 190), each cohort further subdivided into group A (age <35 years) and group B (age ≥35 years). Fresh or frozen embryo transfer was performed as per the standard procedures of the clinic. Pregnancy rates and live birth rate (LBR) were the primary main outcome measures in this study.
Descriptive statistics and Chi-square test were used for analysis.
The number of oocytes retrieved from Gonal-f and biosimilar cohorts were comparable (13.3 vs. 14.4). Compared to biosimilars, Gonal-f treatment resulted in higher yield of cleavage stage and blastocyst stage embryos, and the proportion of women with good quality embryos was higher in the Gonal-f cohort than the biosimilar cohort (83.3% vs. 69.5%). Patients receiving Gonal-f reported higher pregnancy rates (59.2% vs. 39.7%) and LBR (43% vs. 17.7%) compared to those receiving biosimilars.
Gonal-f (originator follitropin) treatment could result in higher pregnancy rates and LBR in comparison to biosimilars in real-world setting.
生物类似药拓宽了辅助生殖技术（ART）的治疗选择范围。需要真实世界的数据来比较原研促卵泡素α（果纳芬）与其生物类似药的临床结局，以丰富关于药物选择临床决策的证据。
比较在临床环境中接受原研促卵泡素（果纳芬）及其生物类似药治疗的患者的ART结局。
对2016年至2020年期间在印度古吉拉特邦阿坎莎医院及研究所接受ART治疗的364名不孕女性的病历进行回顾性分析。
根据治疗情况将参与者分为两个队列（果纳芬队列；n = 174和生物类似药队列；n = 190），每个队列再进一步细分为A组（年龄<35岁）和B组（年龄≥35岁）。按照诊所的标准程序进行新鲜或冷冻胚胎移植。本研究的主要主要结局指标为妊娠率和活产率（LBR）。
采用描述性统计和卡方检验进行分析。
果纳芬队列和生物类似药队列获取的卵母细胞数量相当（13.3个对14.4个）。与生物类似药相比，果纳芬治疗导致分裂期和囊胚期胚胎的产量更高，且果纳芬队列中优质胚胎女性的比例高于生物类似药队列（83.3%对69.5%）。与接受生物类似药的患者相比，接受果纳芬治疗患者的妊娠率（59.2%对39.7%）和LBR（43%对17.7%）更高。
在真实世界环境中，与生物类似药相比，果纳芬（原研促卵泡素）治疗可导致更高的妊娠率和LBR。
