Delving into the Latest Updates on Follitropin Alfa(Finox Ag) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

AFOLIA, Bemfola, Bemfola Pen

+ [8]

Target

FSHR

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

AnovulationHypogonadismPolycystic Ovary Syndrome

Inactive Indication

Infertility

Originator Organization

Finox Biotech AG

Active Organization

Chemical Works of Gedeon Richter Plc

Inactive Organization

Finox Biotech AG

Drug Highest PhaseApproved

First Approval Date

EU (26 Mar 2014),

AnovulationHypogonadismPolycystic Ovary Syndrome

Regulation-

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Gene Sequence

Sequence Code 3246

The sequence is quoted from: *****

Sequence Code 3253

The sequence is quoted from: *****

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

Start Date01 Sep 2016

Sponsor / Collaborator

Finox Biotech AG

EUCTR2015-002214-77-ES / Unknown statusPhase 4

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

Start Date05 May 2016

Sponsor / Collaborator

IVI Madrid SL

100 Clinical Results associated with Follitropin Alfa(Finox Ag)

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100 Translational Medicine associated with Follitropin Alfa(Finox Ag)

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100 Patents (Medical) associated with Follitropin Alfa(Finox Ag)

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93

Literatures (Medical) associated with Follitropin Alfa(Finox Ag)

01 Jun 2024·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

Author: 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.

29 Jun 2023·Aging

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

Article

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

01 Jan 2023·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

Author: 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 Deals associated with Follitropin Alfa(Finox Ag)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA05	DB00066

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anovulation	IS	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	NO	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	LI	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	EU	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	IS	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	LI	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	EU	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	NO	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	EU	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	NO	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	IS	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	LI	Chemical Works of Gedeon Richter Plc	26 Mar 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility	Phase 1	DK	Finox Biotech AG	01 Jun 2010
Infertility	Phase 1	CH	Finox Biotech AG	01 Jun 2010
Infertility	Phase 1	DE	Finox Biotech AG	01 Jun 2010
Infertility	Phase 1	GB	Finox Biotech AG	01 Jun 2010
Infertility	Phase 1	AT	Finox Biotech AG	01 Jun 2010
Infertility	Discovery	ES	Finox Biotech AG	01 Jun 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01687712 (CTgov)	Phase 3	Infertility	1,100	AFOLIA (AFOLIA)	jgzsuvqssc(fgpozbtgeb): Risk Difference (RD) = 3.7 (95% CI, -1.3 to 8.7) View more	-	18 Oct 2017
				Gonal-f® RFF (Gonal-f® RFF)
NCT01121666 (CTgov)	Phase 3	Infertility	460	Follitropin alfa (AFOLIA-150 (Follitropin Alfa))	uhyyplbbnc(heiwgssgqi) = gizrodlmkk wyvwlunfyi (dpgtrvetzx, mcwdvpyyry - nvqcwmsxvl) View more	-	15 Apr 2016
				Follitropin alfa (Gonal-f® (Follitropin Alfa))	uhyyplbbnc(heiwgssgqi) = hrbfroseke wyvwlunfyi (dpgtrvetzx, ikrrotuica - rnizghllor) View more