U.S. License Holder:
Date of License:
Women: GONAL-F (follitropin alfa for injection) is indicated for: Induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure; Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles.
Men: GONAL-F (follitropin alfa for injection) is indicated for induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Bemfola (Finox Biotech / Gedeon Richter) (March-2014)Ovaleap (Teva Pharma) (September-2013)
Biosimilars Approved In Australia
Bemfola / Afolia (Gedeon Richter) (November-2015)
Biosimilars Approved In South Korea
Bemfola (Yooyoung Pharm) (October-2020)