Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysis.

Budani, Maria Cristina; Fensore, Stefania; Di Marzio, Marco; Tiboni, Gian Mario

Recently published multicentre, randomized phase III studies suggested the therapeutic equivalence of biosimilar follitropin alpha medicaments compared to the reference product. The aim of this meta-analysis is to pool the results of the three phase III trials in order to provide an overall analysis about the clinical bioequivalence between biosimilars and the originator. The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) for binary outcomes and the weighted mean difference (WMD) 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 Chi-square tests. No differences were found in term of number of oocytes retrieved at ovum pick-up, the primary endpoint recommended by the European Medicines Agency. No statistical differences were also found for biochemical pregnancy rate, take home baby rate, total follitropin alpha dose, duration of stimulation, and OHSS risk. A significantly higher clinical pregnancy rate (p =.03) was observed in the originator group in comparison to the biosimilar follitropin alpha. Biosimilar follitropin alpha medicaments resulted comparable in comparison to the reference product with respect to the number of oocytes retrieved, that is the primary endpoint recommended by the European Medicines Agency.Further study is needed to evaluate the therapeutic bioequivalence between follitropin alpha biosimilar and the reference medication with respect to secondary endpoints.

EUROPEAN Medicines Agency; FOLLICLE-stimulating hormone; DRUG efficacy; RANDOM effects model; BIOSIMILARS; CHI-squared test

Gynecological Endocrinology, 2021, Vol 37, Issue 5, p406

0951-3590

Academic Journal

10.1080/09513590.2020.1792437