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Journal: Comparative Assessment of the Structural Features of Originator Recombinant Human Follitropin Alfa Versus Recombinant Human Follitropin Alfa Biosimilar Preparations Approved in Non-European Regions. (Pubmed Central) - Jul 2, 2022
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...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.
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Enrollment change, Trial completion date, Trial primary completion date: MSP-IVC: Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF (clinicaltrials.gov) - Mar 24, 2021
P=N/A, N=30, Recruiting,
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. N=100 --> 30 | Trial completion date: Feb 2012 --> Mar 2022 | Trial primary completion date: Dec 2011 --> Dec 2021
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Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Observational Study to Develop Dosing Chart (clinicaltrials.gov) - Aug 7, 2020
P=N/A, N=534, Completed,
In summary, our study indicates that Follitrope Prefilled Syringe is safe and efficacious for ovarian stimulation. Recruiting --> Completed | N=1000 --> 534 | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020
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