重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.)(Follitropin Alfa(Teva Pharmaceutical Industries Ltd.)) - 药物靶点：FSHR_在研适应症：卵巢过度刺激综合征，无排卵，精子发生停滞_专利_临床

概要

基本信息

药物类型

生物类似药、激素

别名

Follitropin alfa biosimilar、Follitropin alfa biosimilar (Teva)、OVALEAP

+ [3]

靶点

FSHR

作用机制

FSHR激动剂(卵泡刺激素受体激动剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病其他疾病

在研适应症

卵巢过度刺激综合征无排卵精子发生停滞

非在研适应症-

原研机构

Teva Pharmaceutical Industries Ltd.

在研机构

Theramex Ireland Ltd.Theramex Australia Pty Ltd

非在研机构

Merckle GmbH

最高研发阶段批准上市

首次获批日期

欧盟 (2013-09-27),

无排卵精子发生停滞

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 3246

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Sequence Code 3253

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关联

5

项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的临床试验

NCT04983173 / Recruiting临床4期IIT

The Impact of the Intensity of Ovarian Stimulation on Embryo Quality in Predicted Suboptimal Responders. A Randomized Controlled Trial

The management of suboptimal ovarian responders remains a challenging task in IVF. These patients are frequently managed with an intense stimulation protocol of ovarian stimulation in order obtain the maximum number of embryos and, therefore, maximize the cumulative live birth rate. However, the concept of "the more the better" has been recently defied by the one of "mild stimulation". Defenders of this protocol state that with mild stimulation only the best quality oocytes are allowed to grow and, therefore, higher quality embryos will be obtained. However, the impact of the intensity of ovarian stimulation on embryo quality is far from consensual. Moreover, its effect on early embryo development has never been evaluated.
Therefore, the investigators set out to perform this randomized controlled trial comparing the number of GQB and the morphokinetic parameters of early embryo development in infertile patients undergoing two different intensities of ovarian stimulation, a milder approach (CC plus 150 IU daily dose of rFSH) and a more intense approach (300 IU daily dose of rFSH).

开始日期2021-11-23

申办/合作机构-

NCT02809989 / CompletedN/A

Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.

The aim of this non-interventional study is to extend the knowledge on effectiveness of Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.

开始日期2016-03-31

申办/合作机构

Teva Pharma

EUCTR2009-017674-20-CZ / Not yet recruitingN/A

Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoingassisted reproductive technologies.A multi-national, multi-centre, randomised, controlled, assessor-blind, parallel groupPhase III study including follow-up periods

开始日期2010-04-27

申办/合作机构

BioGeneriX AG

100 项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的临床结果

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100 项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的转化医学

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100 项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的专利（医药）

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21

项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的文献（医药）

2022-08-01·Drug Discovery Today2区 · 医学

Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get?

2区 · 医学

Article

作者: de Mora, Fernando ; Howles, Colin M

Unfounded skepticism relating to biosimilars, arising from the assertion that they are not molecularly identical to their original counterpart, fails to acknowledge that no biological medicine, including Gonal-f® (from Merck Serono) is identical to itself. Molecular differences between the biosimilar and the reference medicines are irrelevant and clinically undetectable as long as they are contained within the accepted variability for the original medicine. Accordingly, the minor differences in 'ongoing pregnancy rate' and 'live birth' rate reported in a recent meta-analysis of biosimilars of Gonal-f® from Chua et al. are probably driven by product-unrelated factors, notwithstanding the fact that of the four products under analysis, only Ovaleap® (from Theramex UK Ltd) and Bemfola® (from Gedeon Richter Plc) can unambiguously be considered to be biosimilars. The EU Biosimilars model has proven successful, but some healthcare professionals, building on highly arguable premises, voice a distrust in biosimilars. Only if such scientifically unfounded distrust is reverted, the full promise of rFSH alfa biosimilars for reproductive medicine patients is likely to be fulfilled.

2021-10-01·Reproductive BioMedicine Online3区 · 医学

Follitropin alpha versus beta in a first GnRH antagonist ICSI cycle: a retrospective cohort study

3区 · 医学

Article

作者: Van den Haute, Lien ; Verheyen, Greta ; Drakopoulos, Panagiotis ; De Vos, Michel ; Tournaye, Herman ; Blockeel, Christophe

RESEARCH QUESTIONAre cumulative live birth rates (CLBR) after follitropin alpha (Ovaleap®) and follitropin beta (Puregon®) similar when used for ovarian stimulation with ICSI (intracytoplasmic sperm injection) in a first-rank gonadotrophin-releasing hormone (GnRH) antagonist protocol?DESIGNRetrospective single-centre cohort study including 832 infertile patients undergoing ovarian stimulation with a daily dose of 150-225 IU FSH in their first ICSI cycle at a tertiary referral centre between July 2016 and July 2019. Of those, 349 patients used Ovaleap and 483 patients received Puregon.RESULTSBaseline characteristics were not statistically different between the groups. The duration of stimulation was slightly longer in the Ovaleap group (10.6 ± 1.7 versus 10.3 ± 1.6 days; P = 0.012). The number of mature oocytes was not statistically different and there was no significant difference in fertilization rate or embryo utilization rate between the two groups. After fresh embryo transfer, biochemical pregnancy rate (137/349 [39.3%] versus 186/483 [38.5%]) as well as clinical pregnancy rate (105/349 [30.1%] versus 152/483 [31.5%]) were comparable (P = 0.83 and 0.67, respectively). Live birth rate (LBR) after fresh embryo transfer (94/349 [26.9%] versus 141/483 [29.2%]; P = 0.48) and CLBR (199/349 [57.0%] versus 287/483 [59.4%]; P = 0.49) were not significantly different. Multivariable regression analysis revealed that the type of gonadotrophin was not associated with CLBR (P = 0.28).CONCLUSIONThis retrospective study shows no significant difference in CLBR between Ovaleap and Puregon in patients undergoing their first GnRH antagonist ICSI cycle.

2021-07-04·Expert Review of Pharmacoeconomics & Outcomes Research4区 · 医学

The pharmacoeconomic impact of follitropin alpha biosimilars in IVF therapy in Europe: a report of the literature

4区 · 医学

Review

作者: Noventa, Marco ; Dumančić, Stipe ; Ćorić, Mario ; Buzzaccarini, Giovanni ; Šprem Goldštajn, Marina ; Mikuš, Mislav ; Laganà, Antonio Simone ; Orešković, Slavko ; Andrisani, Alessandra

Introduction: To study the impact of biosimilars in assisted reproductive treatments, we performed a review of the literature. Biosimilars are a bioequivalent chemical drug referred to the original. Their production is strongly requested in order to reduce drug cost and reduce health economic impact on national health system. In assisted reproductive treatments different gonadotropin biosimilars are being produced.Areas covered: For this reason, we performed a review of the literature on follitropin alfa Gonal-F biosimilar, Ovaleap and Bemfola, to assess their cost efficacy in national health system. Cost effective (CE) analysis and incremental cost-effectiveness ratio (ICER) were used as parameters for biosimilar impact evaluation in the national health system economy. In particular, they had only slight impact on cost reduction of recombinant follitropin alfa products in Europe.Expert opinion: considering cost-effective analysis, Gonal-F remains the first choice for national health systems. However, well-designed powered methods are strongly needed to assess biosimilars cost-effectiveness.

100 项与重组促卵泡激素α生物类似药(Teva Pharmaceutical Industries Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA05	DB00066

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
卵巢过度刺激综合征	澳大利亚	Theramex Australia Pty Ltd	2021-03-10
无排卵	欧盟	Theramex Ireland Ltd.	2013-09-27
无排卵	列支敦士登	Theramex Ireland Ltd.	2013-09-27
无排卵	冰岛	Theramex Ireland Ltd.	2013-09-27
无排卵	挪威	Theramex Ireland Ltd.	2013-09-27
精子发生停滞	列支敦士登	Theramex Ireland Ltd.	2013-09-27
精子发生停滞	冰岛	Theramex Ireland Ltd.	2013-09-27
精子发生停滞	挪威	Theramex Ireland Ltd.	2013-09-27
精子发生停滞	欧盟	Theramex Ireland Ltd.	2013-09-27