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A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women

Year: 2025

Type: article

Abstract: This study aimed to evaluate the bioequivalence of a novel prefilled recombinant human follicle-stimulating hormone (rh-FSH) injection (GenSci008) compared with the existing rh-FSH for injection (Jinfollin ® ) in healthy Chinese adult women. This open-label, randomized, single-center, two-period, two-sequence crossover study involved 24 healthy female volunteers who received single subcutaneous doses of both formulations, separated by a 10-day washout period. Participants underwent pituitary down-regulation using Diphereline ® to minimize endogenous FSH levels. Pharmacokinetic parameters, including peak concentration ( C max ), area under the drug–time curve from 0 to t (AUC 0-t ), and AUC from 0 to infinity (AUC 0-∞ ) were measured, and bioequivalence was assessed based on the 90% confidence intervals (CIs) falling within the 80.00–125.00% range. Safety and immunogenicity were also evaluated. The geometric mean ratios (GMRs) and 90% CIs for baseline-corrected AUC 0-t , AUC 0-∞ , and C max of the test formulation relative to the reference formulation were 99.99% (93.57–106.86), 102.70% (93.31–113.03), and 93.41% (87.77–99.41), respectively; all within the predefined bioequivalence range. Safety profiles were similar between the two formulations, with no suspected unexpected serious adverse reaction (SUSAR) identified. The novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin ® ), offering a user-friendly and precise alternative for subcutaneous administration in the treatment of infertility.

Source: Drugs in R&D

DOI: 10.1007/s40268-025-00513-w