The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

开始日期2017-02-08

申办/合作机构

IVFarma LLC

[+2]

NCT03857230 / Completed临床1期

Study of Safety, Tolerance and Pharmacokinetics of Primapur and Gonal-f Upon Single-dose Subcutaneous Administration in Healthy Volunteers

The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa preparation (Gonal-F) in healthy young female volunteers.

开始日期2015-10-29

申办/合作机构

IVFarma LLC

[+1]

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2021-08-06·Human Reproduction

P–669 “Follitropin”: A retrospective, observational study comparing the efficacy of follitropin alpha biosimilar therapy in different ovarian stimulation protocols: real-world data

作者: Ushakova, T ; Blinov, D ; Ovchinnikova, M ; Nikitin, S ; Khetagurova, D ; Bendusov, I ; Mayasina, E ; Osina, E ; Barakhoeva, Z ; Ablyaeva, E ; Boyarsky, K ; Ganikhina, M ; Kamilova, D ; Polzikov, M

AbstractStudy questionTo investigate the therapeutic efficacy of follitropin alpha biosimilar therapy in nonselected patients undergoing IVF.Summary answerThis large retrospective study demonstrated similar therapeutic efficacy for follitropin alpha biosimilar therapy in women who underwent ovarian stimulation (OS) using different protocols.What is known alreadyBased on data from the last meta-analyses (Budani et al., 2020), follitropin alpha biosimilars showed similar efficacy and safety in randomized controlled trials aimed at proving the therapeutic equivalence in terms of oocytes retrieved in women undergoing OS. In most cases, normogonadotrophic patients were enrolled in such studies without any endocrine or ovarian disturbances. The absence of real-world data can be compensated by additional post-marketing studies aimed at investigating the efficacy of biosimilars in different OS protocols using antagonists and agonists of GnRH and OS with mixed gonadotropins.Study design, size, durationA retrospective, observational, anonymized cohort study conducted at 35 IVF clinics in Russia, named “FOLLITROPIN”, compared the efficacy of OS in 2020. The OS protocols analysed where follitropin alpha biosimilar (Primapur®) was applied for at least 5 days. All of the analysed subjects underwent OS using GnRH antagonist/agonist protocols, with no restrictions on the OS protocol or food supplements/vitamins. No inclusion or exclusion criteria were applied. Overall, 5484 OS protocols were analysed.Participants/materials, setting, methodsThe efficacy of 5484 OS protocols was calculated, and two subgroups were extracted: (1) mixed gonadotropin OS protocols (N = 2625) vs monotherapy with Primapur® (N = 2859); (2) GnRH antagonist OS (N = 2183) vs GnRH agonist (N = 676) using only Primapur®. Demographic and clinical characteristics: (1) Age 34.9±4.8 vs 32.9±4.7 (p < 0.001), BMI 23.9±4.7 vs 23.6±4.5 (p < 0.001), IVF attempt 1.4±0.7 vs 1.3±0.6 (p < 0.001); (2) Age 32.9±4.6 vs 33.1±4.9 (p = 0.449), BMI 23.7±4.6 vs 23.1±4.5 (p = 0.019), and IVF attempt 1.2±0.5 vs 1.4±0.9 (p < 0.001).Main results and the role of chanceThe total efficacy of OS with Primapur®: oocytes retrieved: 9.5±7.2, MII: 6.8±6.6, 2PN: 6.1±5.8, clinical pregnancy per ET (PR) 6 weeks after ET: 38.4%. Subgroup 1 analysis: oocytes retrieved: 8.6±6.8 vs 10.3±7.4 (p < 0.001), MII: 6.7±6.2 vs 7.7±6.9 (p < 0.001), 2PN: 5.8±5.2 vs 7.2±6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs monotherapy protocols due to subgroup differences, including age, BMI and IVF attempts. No statistically significant differences were found for PR in subgroup 1: 39.3% [95% CI: 36.9–41.7%] vs 37.6% [95% CI: 35.3–39.8%] (p = 0.314). The major accompanying gonadotropin in the mixed protocol was menotropin (75% for mixed OS protocols). Subgroup 2 analysis: oocytes retrieved: 10.5±7.5 vs 9.6±7.0 (p = 0.032), MII: 7.6±6.9 vs 6.7±5.7 (p < 0.001), 2PN: 7.3±6.3 vs 5.7±5.0 (p < 0.001). There were statistically significant differences between oocyte yields in GnRH antagonist vs GnRH agonist monotherapy due to subgroup differences, including BMI and IVF attempts. No statistically significant differences were found for PR in subgroup 2: 37.9% [95% CI: 35.5–40.5%] vs 35.9% [95% CI: 30.8–41.1%] (p = 0.482). All medicines were well tolerated at the injection site, and no serious adverse reactions were reported. This large retrospective cohort study in a nonselected population demonstrated similar clinical efficacy for follitropin alpha biosimilar therapy.Limitations, reasons for cautionThe real-world patient data analysed in this study were representative, showing the ability of follitropin biosimilars to develop both folliculogenesis and clinical pregnancy in a nonselected population. Additional comparative studies are needed to confirm the efficacy of the biosimilars in patients with classified types of infertility causes, including unexplained infertility.Wider implications of the findings: In this study, we demonstrated the therapeutic efficacy of biosimilars in terms of oocyte yield and clinical pregnancy development in women undergoing different OS protocols. Further large-scale studies with known hormonal levels before and during OS, as well as the micro- and macronutrient status of both parents, are needed.Trial registration numberNone

2019-10-01·European Journal of Obstetrics & Gynecology and Reproductive Biology4区 · 医学

A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

4区 · 医学

Article

作者: Morozova, Ekaterina ; Teterina, Tatyana ; Miskun, Anna ; Apryshko, Valentina ; Ovchinnikova, Maria ; Fetisova, Yulia ; Shalinа, Raisa ; Tischenko, Marina ; Zorina, Irina ; Barakhoeva, Zarema ; Sichinava, Lali ; Scherbatyuk, Yulia ; Belousova, Nadezhda ; Marilova, Nina ; Polzikov, Mikhail ; Kolotovkina, Alexandra ; Kasyanova, Galina ; Vovk, Lyudmila ; Yakovenko, Sergey

OBJECTIVEThe aim of the present study was to investigate the therapeutic equivalence between the follitropin alpha biosimilar and the reference medication in women undergoing assisted reproductive technologies (ART).STUDY DESIGNThis multicenter, randomized (1:1), embryologist-blinded, parallel-group, comparative phase III study involved 110 women aged 20-35 years old with tubal and/or male factors of infertility. All of the subjects underwent controlled ovarian hyperstimulation (COH) using a gonadotropin-releasing hormone antagonist (GnRH-ant) protocol. Over the 5-day fixed-dose regimen, the women received 150 IU/day of follitropin alpha biosimilar (n = 55) or original follitropin alpha (n = 55), followed by dose adaptation. The primary endpoint for assessing the therapeutic equivalence was the number of retrieved oocytes using a pre-determined clinical equivalence margin of ± 3.4 oocytes.RESULTSSimilar numbers of oocytes were retrieved in both groups: 12.16 ± 7.28 in the follitropin alpha biosimilar group and 11.62 ± 6.29 in the original follitropin alpha group, with mean difference of 0.546 ± 1.297 oocytes (95% confidence interval [CI]: -2.026, 3.116), p = 0.002 (intention-to-treat [ITT] population). Additionally, no statistically significant differences were found for secondary endpoints: the onset of biochemical (34.7% and 36.7%, p = 0.883), clinical pregnancy (26.5% and 32.7%, p = 0.507), delivery (26.5% and 24.5%, p = 0.817) and take-home baby rate (28.6% and 26.5%, p = 0.816) for the follitropin biosimilar and original follitropin groups (per-protocol [PP] population). Ovarian hyperstimulation syndrome was observed in subjects with a positive pregnancy test in 0% and 3.64% of cases and after triggering ovulation in 7.27% and 3.64% for the follitropin biosimilar and original follitropin groups, respectively.CONCLUSIONSThis study demonstrated similar therapeutic equivalence and safety profiles between the follitropin alpha biosimilar and the reference follitropin in women who underwent COH in GnRH-ant cycles.TRIAL REGISTRATION NUMBER1. Name of the registry: ClinicalTrials.gov.TRIAL REGISTRATION NUMBERNCT03088137. Date of registration: 02.03.2017, retrospectively registered. Trial conducted between 08.02.2017 and 17.08.2018, the date of enrollment of the first participant - 08.02.2017. 2. Name of the registry: Russian Ministry of Health, grls.rosminzdrav.ru.TRIAL REGISTRATION NUMBERRCT 754. Date of registration: 26.10.2016, prospectively registered.

Obstetrics, Gynecology and Reproduction

THE NOVEL BIOSIMILAR OF FOLLITROPIN ALPHA TO BE MANUFACTURED IN RUSSIA STARTING FROM 2017

作者: A. S. Semikhin ; I. I. Vorobiev ; E. O. Golovina

Within the framework of the 27th international conference «Reproductive technologies today and tomorrow», the first Russia-made follitropin alfa biosimilar for controlled ovarian stimulation in assisted reproductive technologies (ART) was presented. The follicle-stimulating hormone (FSH) biosimilar has undergone all stages of development in Russia, from the producer cells culture to the release of active FSH. Also the data are presented on a prospective randomized crossover study of phase I confirming the similarity of pharmacokinetics between the biosimilar and the original FSH. Another randomized multicenter phase III clinical study is now under way aiming to demonstrate the clinical equivalence between the biosimilar and the original FSH; preliminary results of this study are presented and discussed. As planned, the recombinant FSH biosimilar will be produced in disposable injectors (pen-injector) that provide easy-to-use handling, convenient dose setting and wide range dosing.

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