Abstract
BACKGROUND AND OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.