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

Action

agonists

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

European Union (26 Mar 2014),

AnovulationHypogonadismPolycystic Ovary Syndrome

Regulation-

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Structure/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

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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110

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

01 Dec 2024·Expert Opinion on Drug Delivery

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

Article

Author: 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.

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 ; 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.

01 Jun 2024·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

Author: 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 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	Norway	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	Iceland	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	Liechtenstein	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Anovulation	European Union	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	Iceland	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	Liechtenstein	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	Norway	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Hypogonadism	European Union	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	Norway	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	European Union	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	Iceland	Chemical Works of Gedeon Richter Plc	26 Mar 2014
Polycystic Ovary Syndrome	Liechtenstein	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	Preclinical	Denmark	Finox Biotech AG	01 Jun 2010
Infertility	Preclinical	United Kingdom	Finox Biotech AG	01 Jun 2010
Infertility	Preclinical	Switzerland	Finox Biotech AG	01 Jun 2010
Infertility	Preclinical	Germany	Finox Biotech AG	01 Jun 2010
Infertility	Preclinical	Spain	Finox Biotech AG	01 Jun 2010
Infertility	Preclinical	Austria	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)	jpcofafpfi(kfpiblhsjg): 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))	txyerzvyxm(hcpjbhzbsl) = czruibqtff uqnedaivaz (goabdqtaea, uiryccnudr - yscoahwomm) View more	-	15 Apr 2016
				Follitropin alfa (Gonal-f® (Follitropin Alfa))	txyerzvyxm(hcpjbhzbsl) = opzlcerprg uqnedaivaz (goabdqtaea, owwkiohkog - zcihhsecho) View more

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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