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Comparative Studies | Obstetrics and Gynecology | India | Volume 13 Issue 3, March 2024

Comparing Efficacy and Safety of Recombinant FSH Originator Product with Biosimilar in Women Undergoing Ovarian Stimulation

Tanya Shubham | Kundavi Shankar ^[8] | Geetha V. | Rashmi G. V. | Nithya Naaram ^[5]

Abstract: Background: Biosimilar medications have expanded the treatment possibilities within assisted reproductive technology (ART). Real-world data comparing the clinical outcomes of the original follitropin alfa (Gonal-f?) with its biosimilars are essential for enhancing the existing body of evidence to inform clinical decisions regarding drug selection. Aim of the study was to evaluate the efficacy of biosimilar in comparison to recombinant FSH originator product (Gonal F). Methods: This was a Retrospective Observational Study which involved 220 women who underwent IVF treatment for subfertility from Institute of Reproductive Medicine and Women?s Health, Madras Medical Mission Hospital, Chennai between the year 2020 to 2022. Stimulation outcomes and Reproductive outcomes were analysed in terms of number of days of stimulation, total dose of rFSH used, number of embryos obtained, number of embryos transferred, clinical pregnancy rate, multiple pregnancy rate and miscarriage rate. Results: There was no significant difference in the number of oocytes retrieved, number of M2 oocytes retrieved, number of embryos per cycle and embryos transferred between Biosimilars and Gonal F groups. Reproductive outcomes were similar in terms of clinical pregnancy rate. Conclusion: rFSH Biosimilar is as effective as the originator product and similar safety profile.

Keywords: Assisted reproductive technology, follitropin alfa, gonadotropin?releasing hormone antagonist, infertility

Edition: Volume 13 Issue 3, March 2024,

Pages: 759 - 762