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Although the full primary structures of the alfa and beta subunits of reference r-hFSH-alfa and its biosimilars are identical, cell context-dependent differences in the expressing cell lines and manufacturing process can lead to variations in glycosylation profiles. In the present study, we compared the structural features of reference r-hFSH-alfa with those of five biosimilar preparations approved in different global regions outside Europe (Primapur®, Jin Sai Heng®, Follitrope®, Folisurge®, and Corneumon®) with respect to glycosylation, macro- and microheterogeneity, and other post-translational modifications and higher order structure. The mean proportion of N-glycosylation-site occupancy was highest in reference r-hFSH-alfa, decreasing sequentially in Primapur, Jin Sai Heng, Corneumon, Follisurge and Follitrope, respectively. The level of antennarity showed slightly higher complexity in Corneumon, Primapur and Follitrope versus reference r-hFSH-alfa, whereas Jin Sai Heng and Folisurge were aligned with reference r-hFSH-alfa across all N-glycosylation sites. Sialylation level was higher in Corneumon and Follitrope, but small differences were detected in other biosimilar preparations compared with reference r-hFSH-alfa. Jin Sai Heng showed higher levels of N-glyconeuramic acid than the other preparations. Minor differences in oxidation levels were seen among the different products. Therefore, in summary, we identified var ious differences in N-glycosylation occupancy, antennarity, sialylation and oxidation between reference r-hFSH-alfa and the biosimilar preparations analyzed. [ABSTRACT FROM AUTHOR]

This study compared the cost per live birth and cost-effectiveness of the originator recombinant human follicle-stimulating hormone follitropin alfa (r-hFSH-alfa) and r-hFSH-alfa biosimilars for ovarian stimulation prior to assisted reproductive technology treatment in Spain. A decision tree model was developed, comprising pregnancy and live birth for one treatment cycle with fresh embryo transfer. Clinical inputs were based on a recent meta-analysis by Chua et al. [4]. Cost inputs were extracted from publicly available Spanish sources. The costs per live birth were lower with originator r-hFSH-alfa (€18,138) versus r-hFSH-alfa biosimilars (€20,377). The incremental cost-effectiveness ratio was €7208 for originator r-hFSH-alfa versus biosimilars. Drug acquisition costs for originator r-hFSH-alfa represented 10.5% of total costs in the base case analysis, and 6.2% in a treatment cycle resulting in live birth with one fresh embryo transfer. Results from the sensitivity analyses confirmed the robustness of the findings., Competing Interests: Declaration of competing interest SI has received personal fees and non-financial support from Merck Healthcare KGaA, Darmstadt, Germany, Ferring and Gedeon-Richter. EF is an employee of IQVIA Ltd., London, UK. VL was an employee of IQVIA Solutions B.V., Amsterdam, The Netherlands, at the time of the study. CR is an employee of Pharma Value Consulting, Switzerland, and is a consultant for Merck, KGaA Darmstadt Germany. CAV has received personal fees from Merck Healthcare KGaA, Darmstadt, Germany, personal fees, grant, and non-financial support from Merck Healthcare KGaA, Darmstadt, Germany, personal fees and non-financial support from Merck Sharp & Dohme, grant and non-financial support from Ferring, personal fees from Besins, personal fees and non-financial support from Gedeon-Richter, and research funding and non-financial support from Abbott. EAC is an employee of Merck, S.L.U., Madrid, Spain, an affiliate of Merck KGaA. TDH and JES are employees of Merck Healthcare KGaA, Darmstadt, Germany. RM has received personal fees, research funding, grants and non-financial support from Merck Healthcare KGaA, Darmstadt, Germany, and personal fees, grants and non-financial support from Ferring and Gedeon-Richter., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

This was a retrospective real-world evidence analysis of the costs per live birth for reference recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG-HP), based on data from a German in vitro fertilization registry (RecDate). Pregnancy and live birth rates from the RecDate real-world evidence study over three complete assisted reproductive technology (ART) cycles using the same gonadotropin drug were used as clinical inputs. Costs related to ART treatment and to drugs were obtained from public sources. Treatment with r-hFSH-alfa resulted in higher adjusted cumulative live birth rates versus hMG-HP after one (25.3% vs. 22.3%), two (30.9% vs. 27.5%), and three (31.9% vs. 28.6%) ART cycles. Costs per live birth were lower with r-hFSH-alfa versus hMG-HP after one (€17,938 vs. €20,054), two (€18,251 vs. €20,437), and three (€18,473 vs. €20,680) ART cycles. r-hFSH-alfa was found to be a cost-effective strategy compared with hMG-HP over three cycles., Competing Interests: Declaration of competing interest KFB has received honoraria or consultation fees from Merck Healthcare KGaA, Darmstadt, Germany, Ferring, Bayer, Stiftung Endometriose Forschung, and Takeda and is a member of an advisory board for Merck. CR is an employee of Pharma Value Consulting, Switzerland. JES, ML, and TDH are employees of Merck Healthcare KGaA, Darmstadt, Germany. AA was an employee of Merck Healthcare KGaA, Darmstadt, Germany, at the time of the analysis. EF is an employee of IQVIA, Real World Solutions, London, UK. VL is an employee of IQVIA, Real World Solutions, Amsterdam, NL. RF has received honoraria for lectures from Merck Healthcare KGaA, Darmstadt, Germany, and affiliates., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)