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Comparison of recombinant human FSH biosimilar QL1012 with Gonal-f® for ovarian stimulation: a phase-three trial

Published:October 16, 2022DOI:https://doi.org/10.1016/j.rbmo.2022.10.006

      Abstract

      Research question

      Are QL1012 and Gonal-f® equivalent in women undergoing ovarian stimulation for assisted reproductive technology (ART)?

      Design

      Multicentre, randomized, assessor-blinded, phase-three trial conducted at 13 centres in China. Eligible patients were infertile women; age 20–39 years; body mass index 18–30 kg/m2; regular menstrual cycles; and indication for ART. After successful pituitary downregulation, patients were randomly assigned (1:1) to receive QL1012 or Gonal-f®, stratified by age (initial dose of 75–150 IU for women younger than 30 years, 150–225 IU for women aged 30–34 years and 225–300 IU for women aged ≥35 years, subcutaneously, once daily). The primary end point was the number of oocytes retrieved.

      Results

      Between October 2018, and June 2019, 341 patients were included in the per-protocol set. The mean numbers of oocytes retrieved were 14.7 ± 7.0 in the QL1012 group (n = 169) and 13.4 ± 6.1 in the Gonal-f® group (n = 172). Adjusted by analysis of covariance model, the least-squares mean difference was 1.3 oocytes (95% CI –0.1 to 2.7; P = 0.0650), within the pre-defined equivalence margins of ±3.0. Similar results were observed in the full analysis set. Additionally, no statistical differences were found in secondary end points except oestradiol concentration (median 3948.0 pg/ml versus 3545.3 pg/ml; P = 0.0015). Ovarian hyperstimulation syndrome (12.4% versus 13.1 %) and other adverse events were similar between the two groups.

      Conclusions

      Therapeutic equivalence and similar safety profiles were demonstrated between QL1012 and Gonal-f® in women undergoing ovarian stimulation for ART.

      KEYWORDS

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      Biography

      Professor Yingpu Sun is Chief Physician of the Reproductive Medicine Center at First Affiliated Hospital of Zhengzhou University. As a specialist in reproductive medicine, she has successively completed multiple national first cases using advanced assisted reproductive technology.
      Key message
      In this phase-three trial, the equivalence in efficacy and safety were confirmed between QL1012 and reference Gonal-f® in women undergoing ovarian stimulation for assisted reproductive technology, providing the evidence to support QL1012 as a Gonal-f® biosimilar.