Methodological concerns and clinical relevance: a critical appraisal of the meta-analysis on biosimilars versus originator follitropin alfa in ART

Pietro Santulli^{1

2

3

4}, Pedro Brandão⁵, Giuseppe D'Amato^{6

7

8}, Michael Grynberg⁹, Samir Hamamah¹⁰, María Inés Luco¹¹, Roberto Marci¹², Bruno Salle¹³, Thomas Freour¹⁴

Affiliations

¹ Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Universitaire Paris Centre (HUPC), Paris, France.
² Faculté de Médecine, Université Paris Cité, Paris, France.
³ Department of Gynecology and Obstetrics II and Reproductive Medicine (Professor Chapron), Centre Hospitalier Universitaire (CHU) Cochin, Paris, France.
⁴ Department of Development, Reproduction and Cancer, Institut Cochin, INSERM U1016 (Professor Batteux), Université Paris Cité, Paris, France.
⁵ IVI RMA Global Research Alliance, Ginemed Porto, Porto, Portugal.
⁶ Department of Advanced Reproductive Risk Management and High-Risk Pregnancies, ASL Bari, Bari, Italy.
⁷ Reproductive and IVF Unit, PTA Conversano, Conversano, BA, Italy.
⁸ Reproductive Medicine and Gynecology, Faculty of Medicine, University of Tirana, Tirana, Albania.
⁹ Department of Reproductive Medicine and Fertility Preservation, AP-HP-Université Paris-Saclay Antoine Beclère Hospital, Clamart, France.
¹⁰ Department of Reproductive Biology, Arnaud de Villeneuve Hospital, Centre Hospitalier Universitaire Montpellier, INSERM U1203, Montpellier, France.
¹¹ Reproductive Studies Center, CER Clinic, Santiago, Chile.
¹² Department of Translational Medicine, University of Ferrara, Ferrara, Italy.
¹³ Department of Reproductive Medicine and Fertility Preservation, Hospices Civils de Lyon, INSERM U1208, SBRI, Bron, France.
¹⁴ Department of Reproductive Medicine and Biology, CHU Nantes, Nantes Université, INSERM UMR 1064, Nantes, France.

PMID: 40713809
DOI: 10.1093/humrep/deaf144

Editorial

Methodological concerns and clinical relevance: a critical appraisal of the meta-analysis on biosimilars versus originator follitropin alfa in ART

Pietro Santulli et al. Hum Reprod. 2025.

. 2025 Sep 1;40(9):1791-1792.

doi: 10.1093/humrep/deaf144.

Authors

Pietro Santulli^{1

2

3

4}, Pedro Brandão⁵, Giuseppe D'Amato^{6

7

8}, Michael Grynberg⁹, Samir Hamamah¹⁰, María Inés Luco¹¹, Roberto Marci¹², Bruno Salle¹³, Thomas Freour¹⁴

Affiliations

¹ Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Universitaire Paris Centre (HUPC), Paris, France.
² Faculté de Médecine, Université Paris Cité, Paris, France.
³ Department of Gynecology and Obstetrics II and Reproductive Medicine (Professor Chapron), Centre Hospitalier Universitaire (CHU) Cochin, Paris, France.
⁴ Department of Development, Reproduction and Cancer, Institut Cochin, INSERM U1016 (Professor Batteux), Université Paris Cité, Paris, France.
⁵ IVI RMA Global Research Alliance, Ginemed Porto, Porto, Portugal.
⁶ Department of Advanced Reproductive Risk Management and High-Risk Pregnancies, ASL Bari, Bari, Italy.
⁷ Reproductive and IVF Unit, PTA Conversano, Conversano, BA, Italy.
⁸ Reproductive Medicine and Gynecology, Faculty of Medicine, University of Tirana, Tirana, Albania.
⁹ Department of Reproductive Medicine and Fertility Preservation, AP-HP-Université Paris-Saclay Antoine Beclère Hospital, Clamart, France.
¹⁰ Department of Reproductive Biology, Arnaud de Villeneuve Hospital, Centre Hospitalier Universitaire Montpellier, INSERM U1203, Montpellier, France.
¹¹ Reproductive Studies Center, CER Clinic, Santiago, Chile.
¹² Department of Translational Medicine, University of Ferrara, Ferrara, Italy.
¹³ Department of Reproductive Medicine and Fertility Preservation, Hospices Civils de Lyon, INSERM U1208, SBRI, Bron, France.
¹⁴ Department of Reproductive Medicine and Biology, CHU Nantes, Nantes Université, INSERM UMR 1064, Nantes, France.

PMID: 40713809
DOI: 10.1093/humrep/deaf144

No abstract available

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Comment in

Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care.
de Mora F, Howles CM, Trew G. de Mora F, et al. Hum Reprod. 2025 Sep 1;40(9):1789-1790. doi: 10.1093/humrep/deaf143. Hum Reprod. 2025. PMID: 40713789 Free PMC article. No abstract available.
Reply: Biosimilars versus the originator of follitropin alfa in ART: eyes wide shut?
Venetis CA, Kiose KI, Storr A, Mol BW, Kolibianakis EM. Venetis CA, et al. Hum Reprod. 2025 Sep 1;40(9):1793-1796. doi: 10.1093/humrep/deaf145. Hum Reprod. 2025. PMID: 40713868 No abstract available.

Comment on

Biosimilars versus the originator of follitropin alfa for ovarian stimulation in ART: a systematic review and meta-analysis.
Kiose KI, Storr A, Kolibianakis EM, Mol BW, Venetis CA. Kiose KI, et al. Hum Reprod. 2025 Feb 1;40(2):343-359. doi: 10.1093/humrep/deae274. Hum Reprod. 2025. PMID: 39719046 Free PMC article.
Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care.
de Mora F, Howles CM, Trew G. de Mora F, et al. Hum Reprod. 2025 Sep 1;40(9):1789-1790. doi: 10.1093/humrep/deaf143. Hum Reprod. 2025. PMID: 40713789 Free PMC article. No abstract available.
Reply: Biosimilars versus the originator of follitropin alfa in ART: eyes wide shut?
Venetis CA, Kiose KI, Storr A, Mol BW, Kolibianakis EM. Venetis CA, et al. Hum Reprod. 2025 Sep 1;40(9):1793-1796. doi: 10.1093/humrep/deaf145. Hum Reprod. 2025. PMID: 40713868 No abstract available.

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Methodological concerns and clinical relevance: a critical appraisal of the meta-analysis on biosimilars versus originator follitropin alfa in ART

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Methodological concerns and clinical relevance: a critical appraisal of the meta-analysis on biosimilars versus originator follitropin alfa in ART

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