A Cost-Effectiveness Evaluation Comparing Biosimilar Bemfola to Gonal-F for the Treatment of Infertility in an Italian Contest.

Bemfola® (Finox AG, Switzerland), biosimilar follitropin alfa, is a biological medicinal product similar to the originator Gonal-f® (Merck Serono, Germany). Clinical efficacy was demonstrated in an assessor-blinded, randomized, parallel-group, multi-centre, phase III study conducted in women undergoing assisted reproduction techniques on 15 centres in six European countries. (1) Clinical equivalence of Bemfola® to the reference product Gonal-f® was demonstrated in terms of number of oocytes retrieved during stimulation of multi-follicular development in patients undergoing superovulation for assisted reproductive technology (ART). The percentages of patients with a clinical and ongoing pregnancy and live born children was higher in the Gonal-f® group compared with the Bemfola® group for treatment cycle 1, even if it was not statistically significant. In contrast to data from treatment cycle 1, the clinical and ongoing pregnancy rate for Bemfola® and Gonal-f® evaluated from treatment cycle 2 was higher in the Bemfola® group compared with the Gonal-f® group, although not significant. One of the most important adverse events of gonadotropins is ovarian hyper stimulation syndrome (OHSS), reported by more patients in the Bemfola® group in comparison to the Gonal-f® group, 5.6% vs 3.3%, respectively. The majority of these events were mild to moderate.