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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序列信息

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

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

EUCTR2015-002214-77-ES / Unknown status临床4期

Prospective randomized clinical trial to test the efficacy of a biosimilar recombinant FSH (Bemfola) vs. urinary FSH (Fostipur) in an oocyte donation program - Bemfola vs. Fostipur

开始日期2016-05-05

申办/合作机构

IVI Madrid SL

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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93

项与重组促卵泡激素α生物类似药(Finox AG) 相关的文献（医药）

2024-06-01·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 ; Lehmann, Matthieu ; Barrière, Paul

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.

2023-06-29·Aging

Correction for: Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer.

Article

作者: Quan, Song ; Huang, Yuanhua ; Hu, Linli ; Lu, Weiying ; Sun, Yingpu ; Qian, Weiping ; Zhang, Songying ; Lv, Jieqiang

2023-01-01·Journal of Gynecology Obstetrics and Human Reproduction

A real-world study of ART in France (REOLA) comparing a biosimilar rFSH against the originator according to rFSH starting dose

Article

作者: Arbo, Elisangela ; Salle, Bruno ; Sagot, Paul ; Anahory, Tal ; Decanter, Christine ; Massin, Nathalie ; Chabert-Orsini, Véronique ; Bruno, Bruno Salle ; Hamamah, Samir ; Kazdar, Nadia ; Alvarez, Collaborators - Members of the REOLA Study Group: Sylvia ; Courbiere, Blandine ; Pouly, Jean-Luc ; Grzegorczyk-Martin, Véronika ; Chapron, Charles ; Grynberg, Michael ; Jenkins, Julian ; Porcu-Buisson, Géraldine ; Parneix, Isabelle ; Avril, Catherine ; Aubriot, François-Xavier ; Barrière, Paul ; Hocké, Claude ; Belaisch-Allart, Joelle

BACKGROUNDSince the first launch of a biosimilar recombinant follicle stimulating hormone (rFSH), Bemfola®, in Europe in 2014, it has been possible to study in routine clinical care throughout France the effectiveness of a biosimilar rFSH including according to different rFSH starting doses.METHODSREOLA was a non-interventional, retrospective, real world study using anonymized data from 17 Assisted Reproductive Technology (ART) centres' data management systems across France including 2,319 ART ovarian stimulation cycles with Bemfola® and 4,287 ART ovarian stimulation cycles with Gonal-f®. For both products, four populations were studied according to starting dose of rFSH: < 150 IU, 150 - 224 IU, 225 - 299 IU and ≥ 300 IU. The primary endpoint was the cumulative live birth rate (cLBR) per commenced ART ovarian stimulation cycle including all subsequent fresh and frozen-thawed embryo transfers starting during a follow up period of at least 1 year following oocyte retrieval.RESULTSA direct relationship of increasing rFSH starting dose with increasing age, increasing basal FSH, decreasing AMH and increasing body mass index was noted. No clinically relevant differences were seen in all outcomes reported, including the cLBR, between Bemfola® and Gonal-f®, but for both drugs, an association was seen with increasing rFSH starting dose and decreasing cLBR.CONCLUSIONSThe REOLA study demonstrates that the cLBR with Bemfola® is very similar to Gonal-f® across all patient subpopulations. The cLBR is inversely related to the rFSH starting dose irrespective of the drug used, and the REOLA study provides reassurance of the clinical effectiveness of a biosimilar rFSH used in a real world setting.

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	冰岛	Chemical Works of Gedeon Richter Plc	2014-03-26
无排卵	挪威	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	欧盟	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
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	挪威	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1期	丹麦	Finox Biotech AG	2010-06-01
不孕	临床1期	瑞士	Finox Biotech AG	2010-06-01
不孕	临床1期	德国	Finox Biotech AG	2010-06-01
不孕	临床1期	英国	Finox Biotech AG	2010-06-01
不孕	临床1期	奥地利	Finox Biotech AG	2010-06-01
不孕	药物发现	西班牙	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)	餘壓遞選鏇築選製構壓(憲構築醖願顧壓壓積窪): 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))	範製範憲觸膚鹽鑰範繭(獵衊製艱製願獵鏇齋夢) = 鬱構憲壓夢艱廠遞廠構鬱願糧膚鹽鑰艱糧鹹蓋 (築簾鹽膚齋觸淵構網獵, 網築積鏇願衊範願築獵 ~ 膚憲鏇壓顧壓鬱襯選繭) 更多	-	2016-04-15
				Follitropin alfa (Gonal-f® (Follitropin Alfa))	範製範憲觸膚鹽鑰範繭(獵衊製艱製願獵鏇齋夢) = 製淵鏇夢範膚選襯選鹽鬱願糧膚鹽鑰艱糧鹹蓋 (築簾鹽膚齋觸淵構網獵, 築淵獵鹽襯鬱淵顧網積 ~ 願糧築獵齋鹽襯選選顧) 更多