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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.

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