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

肿瘤内分泌与代谢疾病泌尿生殖系统疾病

在研适应症

无排卵性腺机能减退多囊卵巢综合征

非在研适应症-

原研机构

Finox Biotech AG

在研机构

Chemical Works of Gedeon Richter Plc

非在研机构-

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

7

项与重组促卵泡激素α生物类似药(Finox AG) 相关的临床试验

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

NCT02503605 / Unknown status临床4期

Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program

Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.

开始日期2015-10-01

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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90

项与重组促卵泡激素α生物类似药(Finox AG) 相关的文献（医药）

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 ; Chapron, Charles ; Parneix, Isabelle ; Grynberg, Michael ; Porcu-Buisson, Géraldine ; Jenkins, Julian ; Grzegorczyk-Martin, Véronika ; 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.

2022-12-01·Best Practice & Research Clinical Obstetrics & Gynaecology2区 · 医学

Use of a recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for controlled ovarian stimulation during assisted reproductive technology treatment: A real-world study of routine practice in the Russian Federation

2区 · 医学

Article

作者: Koloda, Yulia ; Korsak, Vladislav ; Anshina, Margarita ; Rozenson, Oleg ; Sagamonova, Karina ; Baranov, Igor ; Yakovenko, Sergey ; Ershova, Anna ; Lispi, Monica ; D'Hooghe, Thomas

Two observational studies in the Russian Federation described patient demographics/clinical decision for treatment with recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for ovarian stimulation (OS) during assisted reproductive technology (ART) and outcomes, respectively. The first (prospective) study enrolled 500 patients. After post-hoc regrouping to assign patients to discrete groups, 378 (75.6%) met the local Russian label for an r-hFSH:r-hLH 2:1 combination, 105 (21%) were treated according to other physician preference, and 17 (3.4%) met only the ESHRE Bologna criteria for a poor ovarian response. The clinical pregnancy rate per cycle was 30.4%. A total of 158/175 (90.3%) women achieving clinical pregnancy in the prospective study participated in the second (retrospective) study. The live birth rate per cycle was 25.8%. No new safety concerns were reported. These results support the use of the r-hFSH:r-hLH 2:1 combination in patients with a poor/suboptimal response to OS for ART treatment in the Russian Federation.

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

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	欧盟	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
性腺机能减退	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
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	列支敦士登	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	挪威	Chemical Works of Gedeon Richter Plc	2014-03-26

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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)	選鑰願齋獵憲鬱範窪繭(淵艱繭窪範壓積製餘製): 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))	(夢願窪糧範蓋選廠蓋鹹) = 範願願繭醖壓範齋遞獵鹹獵繭醖遞鏇糧築遞憲 (遞築衊餘網艱獵網簾觸, 觸蓋鏇壓積鹽夢遞繭淵 ~ 選簾鬱範廠獵網範窪積) 更多	-	2016-04-15
				Follitropin alfa (Gonal-f® (Follitropin Alfa))	(夢願窪糧範蓋選廠蓋鹹) = 鬱膚齋艱憲簾鏇顧網積鹹獵繭醖遞鏇糧築遞憲 (遞築衊餘網艱獵網簾觸, 簾範襯憲積蓋蓋構鑰窪 ~ 夢糧壓簾衊顧製襯憲襯) 更多