Efficacy and Safety of Folisurge, a Biosimilar Recombinant Follicle-Stimulating Hormone, Versus Gonal-F in Assisted...

This study was conducted to compare the efficacy and safety of Folisurge, a biosimilar recombinant follicle-stimulating hormone (r-FSH), with Gonal-f, an innovator r-FSH, in patients undergoing assisted reproductive technology (ART).

In this non-interventional, investigator-initiated, real-world, retrospective study, females aged 21-40 years with a body mass index (BMI) ranging between 17 and 34.9 kg/m², with serum anti-Müllerian hormone (AMH) more than 1.2 ng/mL, undergoing controlled ovarian stimulation (COS), and those having received Folisurge or Gonal-f were included. The primary outcome was the mean number of metaphase II (MII) oocytes retrieved in each group. Secondary outcomes included the mean number of embryos formed and serum β-human chorionic gonadotropin (β-hCG) positive rate in each group.

A total of 3090 women were included, out of which 1210 and 1880 received Folisurge and Gonal-f, respectively. The baseline demographics were comparable in the two groups. The mean antral follicle count (AFC) was significantly higher in the Folisurge vs. the Gonal-f group (23.8 vs. 20.6, p < 0.001). Also, the mean (SD) number of oocytes retrieved was significantly higher in the Folisurge vs. the Gonal-f group (18.1 (9.4) vs. 15.5 (8.3), p < 0.001). The mean (SD) number of MII oocytes retrieved with Folisurge was significantly higher than Gonal-f (13 (7.5) vs. 10.9 (6.6), p < 0.001). Also, the mean (SD) number of embryos formed was also higher in the Folisurge vs. the Gonal-f group (4.9 (4.1) vs. 4.7 (4.1), p = 0.022). The serum β-hCG positive rate was similar between the two groups (75.5% vs. 76.2%, p = 0.667). No major safety concerns were observed in the study.

Folisurge was comparable to Gonal-f in terms of serum β-hCG positive rate. The higher yield of oocytes and embryos in the Folisurge group should be interpreted in the context of its higher baseline AFC, which may have influenced these results. No major safety concerns were observed.