Published in:
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
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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. …