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A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

European Journal of Obstetrics & Gynecology and Reproductive Biology Aug 01, 2019

Barakhoeva Z, Vovk L, Fetisova Y, et al. - The therapeutic equivalence between the follitropin alpha biosimilar and the reference medication was examined in women undergoing assisted reproductive technologies. Researchers performed a multicenter, randomized (1:1), embryologist-blinded, parallel-group, comparative phase III study of 110 women (aged 20-35 years old) with tubal and/or male factors of infertility. A gonadotropin-releasing hormone antagonist (GnRH-ant) protocol was applied to perform controlled ovarian hyperstimulation (COH) in all of the subjects. Over the 5-day fixed-dose regimen, they administered 150 IU/day of follitropin alpha biosimilar (n = 55) or original follitropin alpha (n = 55) to the women; this was followed by dose adaptation. Outcomes demonstrate that the follitropin alpha biosimilar and the reference follitropin have similar therapeutic equivalence and safety profiles in women who underwent COH in GnRH-ant cycles.
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