A Phase 3 Noninferiority Study Comparing the Efficacy, Immunogenicity, and Safety of Foligraf®: A Biosimilar Recombinant Human Follicle-stimulating Hormone and Gonal-f® (Prefilled Pen) in Subjects Undergoing Controlled Ovarian Stimulation for Assisted Reproductive Technology

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Infertility is a growing global concern, affecting 60-80 million couples worldwide, with significant prevalence in countries such as India and Russia.1,2 The World Health Organization (WHO) defines infertility as the inability to achieve pregnancy after >12 months of regular, unprotected sexual intercourse 3 ; it is a complex issue with various contributing factors.In women, common causes include polycystic ovarian syndrome (PCOS), 4 endometriosis, 5 poor ovarian reserve, uterine anomalies, tubal damage, and hormonal imbalances.6 Follicle-stimulating hormone (FSH), a key hormone in the regulation of female reproductive processes, plays a central role in gametogenesis and oocyte development.Exogenous FSH has long been utilized in treatments to address fertility issues, 7 and recombinant human FSH (r-hFSH) offers improved potency, safety, and efficacy compared to traditional sources.7,8 This recombinant hormone is integral to assisted reproductive technology (ART), stimulating ovulation in women with anovulatory disorders and supporting controlled ovarian stimulation (COS) in ART cycles.7,9