Advice

following a full submission:

follitropin alfa (Bemfola®) is accepted for use within NHS Scotland.

Indication under review:

In adult women for:
â— anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
â— stimulation of multi-follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
â— in association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and follicle-stimulating hormone (FSH) deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2  units/L.

In adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.

Follitropin alfa (Bemfola®) is a biosimilar that has demonstrated clinical equivalence to another follitropin alfa product for stimulation of multi-follicular development for superovulation in ART. The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.
 

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Medicine details

Medicine name:
follitropin alfa (Bemfola)
SMC ID:
1025/15
Indication:
In adult women for: anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multi-follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; in association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and follicle-stimulating hormone (FSH) deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 units/L. In adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.
Pharmaceutical company
FINOX Biotech
BNF chapter
Endocrine system
Submission type
Full
Status
Accepted
Date advice published
09 February 2015