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Real-World Evidence
Explore key insights from real-world studies.
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Real-world. Real results.
Discover Bemfola®’s efficacy
and safety.
Number of study sites per region of Spain
spain map
BIRTH evaluated four
distinct populations1
spain desc
GnRH, gonadotropin-releasing hormone;
OS, ovarian stimulation.
1. Ferrando M, et al. Fertil Res Pract.
2020;6:13.
Number of study sites per region of Germany and Austria
Germany and Austria Map
German/Austrian NIS: real-
world outcomes with Bemfola®1
germany-austria desc
ART, assisted reproductive technology;
GnRH, gonadotropin-releasing hormone;
NIS, non-interventional study; OS,
ovarian stimulation.
1. Griesinger G, et al. J Reprod Infertil.
2021;22(2):116–124.
Number of study sites per region of France
france map
REOLA studied the real-world
effectiveness of Bemfola® in
centres throughout France1
france desc
GnRH, gonadotropin-releasing hormone;
OS, ovarian stimulation.
1. Ferrando M, et al. Fertil Res Pract.
2020;6:13.
world map
Click on the map to select a study
The effectiveness and safety of Bemfola® was
demonstrated in three large real-world studies1-3
Most ‘real-life’ patients who come for
IVF treatment do not meet the consensus
inclusion and exclusion criteria used in
major clinical trials4
NIS, non-interventional study.
1. Ferrando M, et al. Fertil Res Pract.
2020;6:13; 2. Griesinger G, et al. J
Reprod Infertil. 2021;22(2):116–124; 3.
Barrière P, et al. J Gynecol Obstet Hum
Reprod. 2023;52:10251. 4. Hershkop E,
et al. Reprod Biomed Online.
2017;34(3):274–279
Effective and cost-effective
Bemfola® is cost-effective when compared with alternatives1
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Efficacy
Offering comparable effectiveness at a lower
acquisition price, Bemfola® is a cost-effective
option compared with rFSH alfa originator1,2

Reduced wastage
Use of single-use pens may lead to reduced
drug wastage compared to use of multi-use
pens2
Cost savings
Bemfola® may result in lower drug wastage and
better cost-effectiveness compared with
alternative gonadotropins2,3

rFSH, recombinant follicle stimulating hormone.
1. Lehmann M, et al. Poster presented at the 39th Annual
Meeting of the European Society of Human Reproduction and
Embryology; 25–28 June 2023; Copenhagen, Denmark; 2.
Grynberg M, et al. J Med Econ. 2019;22:108–115. 3. Foxon
G, et al. Hum Fertil (Camb). 2018;21:275–280; 4. Somigliana
E, et al. Eur J Obstet Gynecol Reprod Biol. 2021;267:56–60.
Bemfola Prescribing information & SMPC
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Real-world
studies Cost-effective
Product
information
Highlights
BIRTH evaluated four distinct populations1
BIRTH baseline characteristics1
Bemfola® met treatment requirements for all patient types1
Pregnancy rates were comparable with nationally reported results in Spain1,2
Low number of adverse events with Bemfola®1
Combination therapy of FSH with LH or LH activity was common1
Both implantation and clinical pregnancy rates tended to be lower with combination therapy* vs rFSH alone1
There is a lack of evidence to suggest any beneficial effect of exogenous administration of LH (or LH activity) during ART
Highlights
Baseline characteristics1
Bemfola® doses and duration of stimulation1
Bemfola® was effective in a real-world setting1
Low rate of severe OHSS1
Increase in freeze-all cycles*1
Bemfola® outcomes were consistent with national data for Germany1,2
Highlights
REOLA study endpoints1
REOLA groups were defined according to rFSH starting dose1
REOLA compared patients with similar characteristics1
Doses and duration of stimulation1
Cumulative live-birth rate was very similar between Bemfola® and rFSH alfa originator1
Other reported outcomes were very similar between Bemfola® and rFSH alfa originator1
Comparing treatment groups in real-world studies: logistic regression can be misleading1
Comparison of REOLA with an ART real-world study in France that used logistic regression: study description
Comparison of REOLA with an ART real-world study in France that used logistic regression: results
An expert-validated decision-tree model was developed to investigate the cost-effectiveness of the biosimilar vs originator rFSH alfa over a 1-year time horizon1
Bemfola® is a cost-effective option1
Bemfola® is a cost-effective option1
Cost-effectiveness of rFSH alfa biosimilars vs originator rFSH alfa was assessed according to the results of the relevant Phase III registration trials and costs in France during 20171
Grynberg et al. showed a lower cost per live birth with the biosimilars vs originator1
Potential for drug wastage differs between pen types1
A real-world study in the UK investigated the impact of delivery device on drug wastage during fertility treatment1
Bemfola® may result in lower drug wastage compared with alternative gonadotropins1
Lower drug wastage enhances the cost-effectiveness of Bemfola®1
Real-world data from physicians and nurses were captured across two independent public centres in Italy1
Using Bemfola® instead of rFSH alfa originator may reduce drug wastage1
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