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. 2023 Jan;52(1):102510.
doi: 10.1016/j.jogoh.2022.102510. Epub 2022 Nov 17.

A real-world study of ART in France (REOLA) comparing a biosimilar rFSH against the originator according to rFSH starting dose

Paul Barrière  1 , Samir Hamamah  2 , Elisangela Arbo  3 , Catherine Avril  4 , Bruno Salle  5 , Jean-Luc Pouly  6 , Julian Jenkins  7 ; REOLA study group
Collaborators, Affiliations
Free article

A real-world study of ART in France (REOLA) comparing a biosimilar rFSH against the originator according to rFSH starting dose

Paul Barrière et al. J Gynecol Obstet Hum Reprod. 2023 Jan.
Free article

Abstract

Background: Since 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.

Methods: REOLA 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.

Results: A 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.

Conclusions: The 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.

Keywords: Bemfola; Biosimilar Follitropin; IVF/ICSI; Real world study; rFSH starting dose.

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Conflict of interest statement

Competing interests EA is an employee of Gedeon Richter, and JJ is a scientific advisor to Gedeon Richter. SH received funding for scientific projects from Gedeon Richter, Merck and Ferring. MG received fees from Merck Serono, Ferring, MSD, Besins, GE, Samsung and Gedeon Richter. PB received fees as consultant and/or speaker for Merck, Genevrier, Ferring, Teva, MSD and Gedeon Richter. CA received consulting fees from Gedeon Richter. The other co-authors declare that they have no competing interests. The data analysis was performed by the Contract Research Organisation, Monitoring Force, under the direction of the Medical Affairs department of Gedeon Richter France and the final manuscript was drafted by the Medical Affairs department in collaboration with the authors; in both cases there was no involvement of Gedeon Richter marketing or commercial teams.

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