Patients who underwent assisted reproductive technology (ART) and received originator follitropin alfa (Gonal-f) had higher pregnancy and live birth rates when compared with biosimilar options in a real-world setting, according to a study published in Journal of Human Reproductive Sciences.1
Although effective, follicle stimulating hormone (FSH) treatment accounts for most of the costs associated with ART. Therefore, biosimilars have been introduced to mitigate these costs.2 Medications such as follitropin alfa, along with the variety of biosimilar recombinant human follicle stimulating hormone (r-hFSH) drugs, have expanded the options of gonadotropins for physicians and patients alike. These treatments are used to induce ovulation and follicular stimulation as a part of infertility treatment.3
Key Highlights
- Study findings reveal higher pregnancy and live birth rates in patients undergoing assisted reproductive technology (ART) with originator follitropin alfa compared to biosimilars.
- The retrospective study evaluated medical records of 364 infertile women who underwent ART at Akanksha Hospital and Research Institute in India between 2016 and 2020.
- Patients receiving follitropin alfa originator exhibited higher rates of cleavage stage and blastocyst stage embryos, resulting in improved pregnancy and live birth rates compared to the biosimilar group.
- Pregnancy rates were notably higher in the follitropin alfa group (59.2% vs 39.7% for biosimilar), along with higher live birth rates (43% vs 17.7% for biosimilar).
- Researchers acknowledged limitations such as the retrospective study design, unequal sample sizes, and potential bias, while recognizing the importance of future prospective randomized controlled trials to solidify evidence.
“Although previous studies have compared outcomes with Gonal-f® and its biosimilars, there is paucity in data on differences in reproductive outcomes and under real-world setting,” wrote lead investigator Nayana Hitesh Patel, MD, MBBS, Department of Reproductive Medicine, Akanksha Hospital and Research Institute, Gujarat, India, and colleagues. “This study aims to fill the gap by comparing pregnancy outcome and live birth rates in patients receiving Gonal-f or its biosimilars in a clinical setting.”
The medical records of 364 infertile women who received ART between 2016 and 2020 at the Akanksha Hospital and Research Institute in Gujrat, India, were evaluated retrospectively. Participants were initially categorized as those who were treated with follitropin alfa (n = 174) and those who were treated with its biosimilars (n = 190). Each group was further divided in patients aged <35 years (group A) and patients aged ≥35 years (group B). The fresh or frozen embryo transfer was executed per the standard procedures of the clinic. The primary outcome measures were pregnancy rates and live birth rate.
Demographics and clinical characteristics at baseline were comparable between both groups and most of the overall study population were aged <35 years (n = 234, 78%). Ultimately, the number of oocytes retrieved from both the reference product and biosimilar cohorts were comparable (13.3 vs 14.4, respectively), as were the miscarriage rates.
However, treatment with follitropin alfa resulted in a higher yield of cleavage stage and blastocyst stage embryos, which established a positive association of pregnancy and live birth rate. Additionally, patients treated with follitropin alfa reported a higher proportion of patients with good quality embryos when compared with the biosimilar group (83.3% vs 69.5%, respectively). When compared with patients receiving biosimilars, patients treated with the follitropin alfa originator experienced higher pregnancy rates (59.2% vs 39.7%, respectively) and live birth rates (43% vs 17.7%, respectively).
Investigators noted the retrospective study design, which may have hindered definite conclusions due to obscure bias. Another limitation was the unequal sample size among both groups, which may have altered the success rate of outcomes. However, including live birth rate as a primary outcome strengthened the study, as previous studies have considered this to be a secondary outcome. Investigators recognized the increasing consensus on the link between ongoing pregnancy and live birth rate. Including the miscarriage rate, the number of good embryos, the number of embryos transferred, the clinical pregnancy rate, and the larger sample size further strengthened results.
However, investigators acknowledged, “Statistically adequate prospective randomized controlled trials (RCTs) provide robust evidence, thereby suggesting the necessity for RCTs. In addition, the cost-effectiveness, treatment complexity, patient burden and pregnancy complications of both products should be taken into account in future analyses.”
References
- Patel NH, Patel NH, Patel MN, Bhadarka HK, Vyas KS. Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study. J Hum Reprod Sci. 2023;16(2):148-155. doi:10.4103/jhrs.jhrs_37_23
- Bergandi L, Canosa S, Carosso AR, Paschero C, Gennarelli G, Silvagno F, et al. Human recombinant FSH and its biosimilars: Clinical efficacy, safety, and cost-effectiveness in controlled ovarian stimulation for in vitro fertilization. Pharmaceuticals (Basel) 2020;13:136
- Braam SC, de Bruin JP, Buisman ET, Brandes M, Nelen WL, Smeenk JM, et al. Treatment strategies and cumulative live birth rates in WHO-II ovulation disorders. Eur J Obstet Gynecol Reprod Biol. 2018;225:84–9
