An updated meta-analysis comparing the efficacy and safety of biosimilar medicinal products to the original follitropin alfa.

Abstract

Introduction: The aim of this study was to provide an updated meta-analysis assessing the therapeutic equivalence between follitropin alfa biosimilars and the reference medication in women undergoing assisted reproductive technologies (ART).

Evidence acquisition: The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) for binary outcomes and the mean difference (MD) for continuous outcomes along with the corresponding 95% confidence intervals (CI) by using a random effects model. The heterogeneity between the studies was evaluated with the Higgins and χ² tests.

Evidence synthesis: No differences were found concerning the number of oocytes retrieved at ovum pick-up, the primary endpoint recommended by the European Medicines Agency (EMA) (MD -0.04 CI [-0.78, 0.71], P=0.92). A significantly higher clinical pregnancy rate (OR 0.70 CI [0.53, 0.93], P=0.01) was observed in the reference product group in comparison to the biosimilar follitropin alfa, whereas no statistically significant differences were found for biochemical pregnancy rate, take home baby rate, total follitropin alfa dose, duration of stimulation, and ovarian hyperstimulation syndrome risk.

Conclusions: The non-inferiority of biosimilar formulations in comparison to the reference product, with respect to number of oocytes retrieved at ovum pick-up, was shown.