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* On November 30, 2015, Finox Biotech announced that the Therapeutic Goods Administration (TGA), has granted a Marketing Authorisation (MA) for Bemfola® (follitropin alfa solution for injection in pre-filled pens), the first follicle stimulating hormone biosimilar therapy used for the treatment of infertility . The TGA decision allows Finox Biotech to market Bemfola® in Australia.
Bemfola® is registered in Australia for the treatment of infertility in adult women and adult men. In adult women Bemfola® is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated;- Controlled ovarian hyper stimulation in women undergoing assisted reproductive technologies;- Bemfola® in association with luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with serve LH and FSH deficiency. In clinical trials these patients were defined by endogenous serum LH level < 1.2 IU/l;- In adult Men Bemfola® is indicated with the concomitant human chorionic gonadotropin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

* On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Bemfola® (follitropin alfa) intended for the treatment of fertility disorders. The benefits with Bemfola® are its ability for the treatment of fertility disorders. The most common side effects are headache, ovarian cysts and local injection site reactions. Mild or moderate Ovarian Hyperstimulation Syndrome (OHSS) has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Thromboembolism may occur very rarely, usually associated with severe OHSS. A pharmacovigilance plan for Bemfola® will be implemented as part of the marketing authorisation. The approved indication is:

In adult women:

• Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.

• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).

• Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.

In adult men:

• Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.

It is proposed that Bemfola® be prescribed by physicians experienced in the treatment of treatment of fertility disorders.