FDA Clears rFSH Products From Serono, Akzo Nobel

Ares-Serono and Organon, the two major players in the gonadotrophinmarket, have both been granted approval in the USA for their recombinant follicle-stimulating hormone products, for use in assisted reproduction techniques.

Serono said it would be launching Gonal-F (follitropin alfa) in the USA shortly. It is already available in Europe and Canada. Organon also said that it would be launching its Follistim (follitropin beta; known as Puregon elsewhere) product in the near future. Both the new products are given by subcutaneous injection, which is an important advantage compared to the postmenopausal urine-derived products (Serono's Metrodin and Metrodin HP and Organon's Humegon and Follegon), which are given by intramuscular injection. There is also no limitation with supply, which had been a problem with the older drugs.

The recombinant products are actually cheaper to make than the urine-derived versions, and yet the companies can command a higher price for them. Both companies will seek to switch patients from the old to the new. This may be a slow process, especially given the reluctance of the health services in some countries to reimburse for the treatment. However, the recombinant products have an efficacy advantage (one in four successful pregnancies rather than one in five), and so will likely come to dominate the market. There are still no clear indications that either Gonal-F or Follistim have an efficacy advantage over each other.