重组促卵泡激素α生物类似药(Finox AG)(Follitropin Alfa(Finox Ag)) - 药物靶点：FSHR_在研适应症：无排卵，性腺机能减退，多囊卵巢综合征_专利_临床

概要

基本信息

药物类型

生物类似药、激素

别名

AFOLIA、Bemfola、Bemfola Pen

+ [8]

靶点

FSHR

作用方式

激动剂

作用机制

FSHR激动剂(卵泡刺激素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Chemical Works of Gedeon Richter Plc

非在研机构

Finox Biotech AG

最高研发阶段批准上市

首次获批日期

欧盟 (2014-03-26),

无排卵性腺机能减退多囊卵巢综合征

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 3246

当前序列信息引自: *****

Sequence Code 3253

当前序列信息引自: *****

关联

8

项与重组促卵泡激素α生物类似药(Finox AG) 相关的临床试验

ChiCTR2400094481

/ SuspendedN/AIIT

A real-world study of the efficacy of recombinant human follicle-stimulating hormone in the treatment of boys with congenitally hypogonadotropic hypogonadism

开始日期2024-12-25

申办/合作机构-

NCT02941341

/ CompletedN/A

Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.

Non-comparative, observational, ambispective post-authorisation study (EPA-SP).

开始日期2016-10-01

申办/合作机构

Finox Biotech AG

NCT02942849

/ CompletedN/A

Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression

开始日期2016-09-01

申办/合作机构

Finox Biotech AG

100 项与重组促卵泡激素α生物类似药(Finox AG) 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(Finox AG) 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(Finox AG) 相关的专利（医药）

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110

项与重组促卵泡激素α生物类似药(Finox AG) 相关的文献（医药）

2024-12-01·Expert Opinion on Drug Delivery

Patient preferences on pen injectors for assisted reproductive technology: a discrete choice experiment in France

Article

作者: Arcelin, Thelma ; Castello-Bridoux, Claire ; Ranisavljevic, Noémie ; Vaugon, Sabrina ; Grynberg, Michaël ; Nuyttens, Céline ; Baffert, Sandrine ; Yazbeck, Chadi ; Luciani, Laura ; Marino, Patricia ; Kirion, Justin ; Bernard, Caroline

BACKGROUNDThe preference of patients in the choice of pen injectors for Assisted Reproduction Technology (ART) is an important issue for treatment adherence. This study, based on discrete choice experiment (DCE), aimed to elicit patients' preferences of the characteristics of all pen injectors available in France.RESEARCH DESIGN AND METHODSA DCE with 12 choice sets was developed to measure the preferences of 6 attributes: pre-injection steps, injection device, dose release, post-injection display, dose reduction method, and dose counter. A mixed logistic model was used to determine the preference ranks and calculate utility score.RESULTSThe study involved 155 women who had previous experience with the use of injector pens with an average age of 34.1 years. Statistically significant results showed that the most essential characteristics were dose confirmation (p < 0.0001), dose counter with digits (p < 0.0001), multi-use pen (p < 0.0001) and ready-to-use pens (p < 0.0001). Estimation of the utilities showed statistically significant difference in favor of Gonal-f®/Pergoveris® (reference modalities) versus other pens, and the largest difference was with Rekovelle® [95% CI:-1,37;-0.85], and Bemfola® [95% CI:-2.25;-1,52].CONCLUSIONSThis study show that respondent preferred pen that are ready to use, can be used multiple times, have dose injection confirmation, and display the dose with digits.

2024-06-01·European Journal of Obstetrics & Gynecology and Reproductive Biology: X

Determining the cost-effectiveness of follitropin alfa biosimilar compared to follitropin alfa originator in women undergoing fertility treatment in France

Article

作者: Pouly, Jean-Luc ; Boland, Lauren Amy ; Jenkins, Julian ; Arbo, Elisangela ; Bean, Samuel George ; Barrière, Paul ; Lehmann, Matthieu

ObjectiveThe study assessed cost-effectiveness of follitropin alfa biosimilar versus the originator in terms of cost per cumulative live-birth (CLB) for the French healthcare system based on real-world evidence. Follitropin alfa biosimilars have been shown to have comparable clinical outcomes to the originator, in both clinical studies and real-world settings, in terms of oocyte retrieval and cumulative live-birth rate (CLBR). Previous health economic studies comparing the cost-effectiveness of follitropin alfa biosimilars against the originator utilised clinical trial data, leaving ambiguity over cost-effectiveness in real-world settings. Additionally, previous cost-effectiveness analysis has been performed for live-births following only fresh embryo transfers, whereas, fresh and frozen transfers are common in clinical practice. This study investigates the cost per CLB, which more closely models clinical practice.Study designA decision-tree cost-effectiveness model was developed based on the total costs and CLBR per ovarian stimulation (OS) for a follitropin alfa biosimilar (Bemfola®, Gedeon Richter Plc, Budapest, Hungary) and the originator (Gonal-f®, Merck KGaA, Darmstadt, Germany). A time horizon of one year from oocyte retrieval to embryo transfer was used but costs from resulting transfers were also included. Clinical inputs were taken from the REOLA real-world study or clinician insights, while acquisition costs were taken from French public databases. The output was cost per CLB following one OS. One-way sensitivity analysis was performed to determine the largest model drivers.ResultsCost per CLB was €18,147 with follitropin alfa biosimilar and €18,834 with the originator, saving €687 per CLB following OS with the biosimilar. When wastage estimates were considered the biosimilar cost saving is estimated to be between €796 and €1155 per CLB further increasing cost savings. Irrespective of wastage, if used ubiquitously throughout France for ART, the biosimilar could save the French health system €13,994,190 or lead to 771 more births when compared to its higher-cost originator. Sensitivity analysis showed that the originator's relative CLBR had the greatest impact on the model.ConclusionThis analysis demonstrates that the follitropin alfa biosimilar, Bemfola®, is a more cost-effective option for OS compared with the originator from a French healthcare payer perspective, in terms of cost per CLB.

2024-06-01·Reproductive BioMedicine Online

Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35–40 years

Article

作者: Fischer, Robert ; Schwarze, Juan-Enrique ; Chuderland, Dana ; D'Hooghe, Thomas ; Bielfeld, Alexandra P ; Lispi, Monica ; Hayward, Brooke ; Verpillat, Patrice ; Krussel, Jan-Steffan

RESEARCH QUESTIONAccording to real-world data, is recombinant human FSH (r-hFSH) combined with recombinant human LH (r-hLH) or r-hFSH alone more effective for women of advanced maternal age (AMA) in terms of live birth?DESIGNNon-interventional study comparing the effectiveness of r-hFSH and recombinant r-hLH (2:1 ratio) versus r-hFSH alone for ovarian stimulation during ART treatment in women aged 35-40 years, using real-world data from the Deutsches IVF-Register.RESULTSOverall clinical pregnancy (29.8%, 95% CI 28.2 to 31.6 versus 27.8%, 95% CI 26.5 to 29.2) and live birth (20.3%, 95% CI 18.7 to 21.8 versus 18.0%, 95% CI 16.6 to 19.4) rates were not significantly different between the combined r-hFSH and r-hLH group and the r-hFSH alone group (P = 0.269 and P = 0.092, respectively). Treatment effect was significantly higher for combined r-hFSH and r-hLH compared with r-hFSH alone for clinical pregnancy (33.1%, 95% CI 31.0 to 35.0 versus 28.5%, 95% CI 26.6 to 30.4; P = 0.001, not adjusted for multiplicity) and live birth (22.5%, 95% CI 20.5 to 24.2 versus 19.4%, 95% CI 17.6 to 20.9; P = 0.014, not adjusted for multiplicity) in a post-hoc analysis of women with five to 14 oocytes retrieved (used as a surrogate for normal ovarian reserve), highlighting the potential benefits of combined r-hFSH and r-hLH for ovarian stimulation in women aged 35-40 years with normal ovarian reserve.CONCLUSIONSWomen of AMA with normal ovarian response benefit from treatment with combined r-hFSH and r-hLH in a 2:1 ratio versus r-hFSH alone in terms of live birth rate. The effectiveness of treatments is best assessed by RCTs; however, real-world data are valuable for examining the effectiveness of fertility treatment, especially among patient groups that are not well represented in clinical trials.

100 项与重组促卵泡激素α生物类似药(Finox AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA05	DB00066

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
无排卵	挪威	Chemical Works of Gedeon Richter Plc	2014-03-26
无排卵	冰岛	Chemical Works of Gedeon Richter Plc	2014-03-26
无排卵	列支敦士登	Chemical Works of Gedeon Richter Plc	2014-03-26
无排卵	欧盟	Chemical Works of Gedeon Richter Plc	2014-03-26
性腺机能减退	冰岛	Chemical Works of Gedeon Richter Plc	2014-03-26
性腺机能减退	列支敦士登	Chemical Works of Gedeon Richter Plc	2014-03-26
性腺机能减退	挪威	Chemical Works of Gedeon Richter Plc	2014-03-26
性腺机能减退	欧盟	Chemical Works of Gedeon Richter Plc	2014-03-26
多囊卵巢综合征	挪威	Chemical Works of Gedeon Richter Plc	2014-03-26
多囊卵巢综合征	欧盟	Chemical Works of Gedeon Richter Plc	2014-03-26
多囊卵巢综合征	冰岛	Chemical Works of Gedeon Richter Plc	2014-03-26
多囊卵巢综合征	列支敦士登	Chemical Works of Gedeon Richter Plc	2014-03-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
不孕	临床前	丹麦	Finox Biotech AG	2010-06-01
不孕	临床前	英国	Finox Biotech AG	2010-06-01
不孕	临床前	瑞士	Finox Biotech AG	2010-06-01
不孕	临床前	德国	Finox Biotech AG	2010-06-01
不孕	临床前	西班牙	Finox Biotech AG	2010-06-01
不孕	临床前	奥地利	Finox Biotech AG	2010-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01687712 (CTgov)	临床3期	不孕	1,100	AFOLIA (AFOLIA)	夢憲鏇範遞鹹選簾鹽齋(夢繭築鑰製艱網醖鑰醖): Risk Difference (RD) = 3.7 (95% CI, -1.3 ~ 8.7) 更多	-	2017-10-18
				Gonal-f® RFF (Gonal-f® RFF)
NCT01121666 (CTgov)	临床3期	不孕	460	Follitropin alfa (AFOLIA-150 (Follitropin Alfa))	壓醖蓋淵鏇壓糧鏇願繭(艱憲製觸夢積窪餘鏇鏇) = 襯鹹積糧網顧簾鏇鹹膚獵顧簾衊網餘艱製築遞 (淵簾蓋製襯餘醖淵網簾, 鑰鹹鏇願齋膚觸構觸壓 ~ 窪觸選築齋鏇憲壓蓋齋) 更多	-	2016-04-15
				Follitropin alfa (Gonal-f® (Follitropin Alfa))	壓醖蓋淵鏇壓糧鏇願繭(艱憲製觸夢積窪餘鏇鏇) = 衊壓觸夢製遞鹽範繭積獵顧簾衊網餘艱製築遞 (淵簾蓋製襯餘醖淵網簾, 窪遞艱淵鹽築鏇醖憲襯 ~ 齋憲衊壓顧積製鏇艱願) 更多