The submission of the MAA is a major milestone for the Switzerland-based biotech company and its lead product r-FSH Bemfola (development code ‘Afolia’). The Bemfola MAA was based on a comprehensive clinical development programme in which Bemfola was demonstrated to be statistically equivalent to the reference product [Gonal-f (follitropin alfa)] in patients participating in an Assisted Reproductive Technology (ART) pivotal phase III clinical trial.

The pivotal phase III clinical trial was completed in June 2012 and proved equivalence of the two treatments by retrieving similar numbers of oocytes (immature female ova or egg cells) during a standard treatment duration of 10 to 16 days with a fixed dose of r-FSH. The results of the trial proved the ‘biosimilarity’ of Bemfola to Gonal‑f. The number of oocytes retrieved was 11.3 in the Bemfola group, compared to 10.8 in the Gonal-f group. The treatment difference was 0.52 with a 95% confidence interval of -0.81 to 1.79, which fell within the pre-defined equivalence margin of ± 2.9 oocytes.

Merck Serono’s Gonal-f is used for the treatment of female infertility and was authorized for use in the EU in October 1995. The patent on Gonal-f expired in the EU in 2009 and in the US the patent is due to expire in 2015. Worldwide sales of Gonal-f in 2011 were Euros 526 million.

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