TY - JOUR
T1 - Biosimilars versus the originator of follitropin alfa
T2 - Randomized controlled trials are still the best way to evaluate their comparative effectiveness in assisted reproduction
AU - Venetis, Christos A.
AU - Mol, Ben W.
N1 - Funding Information:
Ben came to Australia in 2014 and has worked as Professor Obstetrics & Gynaecology at Monash University since 2018. Ben has been holding continuous NHMRC funding since 2014, including a prestigious investigator grant. He continues to develop extensive relations with Asian universities whilst continuing to collaborate within European networks. Ben has mentored >110 PhD students and has published >1500 papers, many in high impact journals. A publication in Nature acknowledged Ben as one of the most prolific medical scientists. His professional adage is ‘A day without randomisation is a day without progress.
Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2023/2
Y1 - 2023/2
N2 - Biosimilars of follitropin alfa have been introduced in many countries as more affordable alternatives to the reference product for patients undergoing ovarian stimulation for assisted reproductive technology cycles. A recent meta-analysis, by reviewing available evidence originating from randomised controlled trials, has shown that based on the best available evidence, biosimilars of follitropin alfa are associated with lower live birth, ongoing and clinical pregnancy rates compared to the reference product. A subsequently published opinion paper challenges the methodology and results of this meta-analysis and suggests that these data should be ignored. In the present paper, it is clearly demonstrated why this criticism is largely unfounded and in stark contradiction with basic principles of evidence-based medicine. Furthermore, it is presented why the results of this meta-analysis provide the best available evidence to date and therefore the base that should inform clinical practice and, importantly, stimulate further research.
AB - Biosimilars of follitropin alfa have been introduced in many countries as more affordable alternatives to the reference product for patients undergoing ovarian stimulation for assisted reproductive technology cycles. A recent meta-analysis, by reviewing available evidence originating from randomised controlled trials, has shown that based on the best available evidence, biosimilars of follitropin alfa are associated with lower live birth, ongoing and clinical pregnancy rates compared to the reference product. A subsequently published opinion paper challenges the methodology and results of this meta-analysis and suggests that these data should be ignored. In the present paper, it is clearly demonstrated why this criticism is largely unfounded and in stark contradiction with basic principles of evidence-based medicine. Furthermore, it is presented why the results of this meta-analysis provide the best available evidence to date and therefore the base that should inform clinical practice and, importantly, stimulate further research.
KW - Biosimilars
KW - Follitropin alfa
KW - In vitro fertilisation
KW - Live birth
KW - Meta-analysis
KW - Ovarian stimulation
KW - Pregnancy
KW - Randomised controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85141490160&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2022.103425
DO - 10.1016/j.drudis.2022.103425
M3 - Editorial
C2 - 36332833
AN - SCOPUS:85141490160
SN - 1359-6446
VL - 28
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 2
M1 - 103425
ER -