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

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), area under the drug-time curve from 0 to t (AUC), and AUC from 0 to infinity (AUC) 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, AUC, and C 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.