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

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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.

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

2021-04-13

·GlobeNewswire

New York, April 13, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Top 50 Biosimilar Drug Manufacturers 2021" - PLUS Regional Market Analysis AND COVID-19 Recovery ScenariosTop 50 Biosimilar Companies Report– Read on to determine how you can exploit the impending business opportunities emerging in this sector along with profile of top 50 companies operating in the market. 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Discover sales forecasts for the global and regional market forecasts from 2020-2023 Along with revenue prediction for the overall global market, there is segmentations by product for 20 major biosimilar drugs and 5 regional markets including North America, Europe, Asia Pacific, Latin America, and MEA. Global market revenue and growth forecasts from 2020 to 2023 by product The global biosimilars market revenue will surpass $16.57 billion in 2020 with a lucrative CAGR during the forecast period 2021-2023 to reach significant revenue growth to 2023. The major product considered in the report are: • Adalimumab • Etanercept • Trastuzumab • Infliximab • Insulin Glargine • Rituximab • Pegfilgrastim • Epoetin Alfa • Teriparatide • Bevacizumab • Insulin Lispro • Darbepoetin Alfa • Filgrastim • Enoxaparin • Eculizumab • Natalizumab • Cetuximab • Follitropin Alfa • Somatropin • Dornase Alfa • Other Biosimilars Regional market revenue and growth forecasts from 2020 to 2023: • North America • Europe • Asia Pacific • Latin America • Middle East and Africa Leading companies and those seeking to enter the market The report includes profiles of 50 major companies involved in the Biosimilar Market. The companies profiled in this report include: Amgen Inc.; Novartis AG; Merck & Co., Inc.; Pfizer Inc.; Eli Lilly and Company; Biogen Inc.; Teva Pharmaceutical Industries Ld.; Celltrion Healthcare Co., Ltd.; Sanofi; Samsung Bioepis; Mylan N.V.; Fresenius Kabi AG; Intas Pharmaceuticals Ltd.; AbbVie Inc.; STADA Arzneimittel AG ; Coherus; Dr Reddy’s Laboratories Ltd.; Boehringer Ingelheim International GmbH; Daiichi Sankyo Co Ltd.; Biocon Ltd.; Nichi-Iko; Fujifilm Kyowa Kirin Biologics; Zydus Cadila; Apotex Inc.; Lupin Ltd.; PolPharma; Zhejiang Hisun Pharma; Cipla Ltd.; Generium; Torrent Pharma; Shenzhen Techdow Pharmaceutical; Mochida; Gedeon Richter Plc.; Aurobindo Pharma; USV Biologics; Egis Pharmaceuticals Plc.; Hetero; Ligand Pharmaceuticals; Xbrane Biopharma AB; Alvotech; Mabion S.A.; Reliance Life Sciences; Harvest Moon Pharmaceuticals; AryoGen; Jiangsu Simcere Pharmaceutical; Mundipharma International Ltd.; Kashiv Biosciences; Gene Techno Science; Avesthagen Pharma AG; Formycon AG. 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It will be useful for businesses who wish to better comprehend the part of the market they are already involved in, or those wishing to enter or expand into a different regional market or to understand strategic analysis of leading 50 companies of the biosimilars industry.Read the full report: ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA05	DB00066

研发状态

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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