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Open Access 01-12-2016 | Letter to Editor

Comment on “Biosimilar FSH preparations- are they identical twins or just siblings?”

Authors: Thomas Strowitzki, Waldemar Kuczynski, Arnd Mueller, Peter Bias

Published in: Reproductive Biology and Endocrinology | Issue 1/2016

Excerpt

We read with interest the editorial by Orvieto and Seifer [1] on the EU approved r-hFSH biosimilar products Ovaleap® [2] and Bemfola® [3] and the reference Gonal-f®. We were surprised by the negative tone and seeming dismissal of EMA guidelines [4] for the development and marketing authorization of r-hFSH biosimiliars. The editorial questions the legal basis for r-hFSH biosimilar registration and use in clinical practice. We comment on the development and role of r-hFSH biosimilars and correct errors and omissions in the editorial. …

Orvieto R, Seifer DB. Biosimilar FSH preparations- are they identical twins or just siblings? Reprod Biol Endocrinol. 2016;14(1):32.CrossRefPubMedPubMedCentral

Strowitzki T, Kuczynski W, Mueller A, Bias P. Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART). Reprod Biol Endocrinol. 2016;14(1):1.CrossRefPubMedPubMedCentral

Rettenbacher M, Andersen AN, Garcia-Velasco JA, et al. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015;30(5):504–13.CrossRefPubMed

European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH). London: European Medicines Agency; February 21, 2013

Sunkara SK, Rittenberg V, Raine-Fenning N, Bhattacharya S, Zamora J, Coomarasamy A. Association between the number of eggs and live birth in IVF treatment: an analysis of 400 135 treatment cycles. Hum Reprod. 2011;26(7):1768–74.CrossRefPubMed

Strowitzki T, Kuczynski W, Mueller A, Bias P. Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study. Reprod Biol Endocrinol. 2016;14(1):31.CrossRefPubMedPubMedCentral

Title: Comment on “Biosimilar FSH preparations- are they identical twins or just siblings?”
Authors: Thomas Strowitzki
Waldemar Kuczynski
Arnd Mueller
Peter Bias
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Reproductive Biology and Endocrinology / Issue 1/2016
Electronic ISSN: 1477-7827
DOI: https://doi.org/10.1186/s12958-016-0196-3

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Comment on “Biosimilar FSH preparations- are they identical twins or just siblings?”

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