Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2025 Sep 1;40(9):1789-1790.
doi: 10.1093/humrep/deaf143.

Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care

Fernando de Mora  1 , Colin M Howles  2   3 , Geoffrey Trew  4
Affiliations
Editorial

Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care

Fernando de Mora et al. Hum Reprod. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

F.D.M. has worked as a consultant for Liomont and mAbxience, has worked as a consultant and/or speaker for Amgen, Celltrion, Eli Lilly, Gedeon Richter, Merck Serono, Novartis, Pfizer, Roche, Sandoz and Theramex, and has received Honoria from Abbott and Liomont. C.M.H. is currently a consultant for Theramex UK; consulting fees, honoraria and travel support has been paid to ARIES Consulting Sàrl. G.T. has received a speaker’s fee and travel support from Theramex UK.

Comment in

Comment on

References

    1. Bielsky MC, Cook A, Wallington A, Exley A, Kauser S, Hay JL, Both L, Brown D. Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial. Drug Discov Today 2020;25:1910–1918. - PubMed
    1. Correia-Pinheiro L, Giezen TJ, Wolff-Holz E, Weise M, Laslop A, Hidalgo-Simon A. Identifiability of biologicals: an analysis using EudraVigilance, the European Union’s database of reports of suspected adverse drug reactions. Clin Pharmacol Ther 2021;110:1311–1317. - PMC - PubMed
    1. European Medicines Agency. Reflection Paper on a Tailored Clinical Approach in Biosimilar Development. 2025. https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-c... (19 May 2025, date last accessed).
    1. Guillen E, Ekman N, Barry B, Weise M, Wolff-Holz E. A data driven approach to support tailored clinical programs for biosimilar monoclonal antibodies. Clin Pharmacol Ther 2023;113:108–123. - PubMed
    1. Kaplan S, Levy-Toledano R, Davies M, Roy D, Howles CM, Lass A. Safety of Ovaleap® (follitropin alfa) in infertile women undergoing superovulation for ART: a multinational comparative, prospective cohort study. Front Endocrinol 2021;12:632674. - PMC - PubMed