Friday, December 14, 2012

Biosimilar application for Rhfsh, follitropin alfa submitted to EMA

EMA has received an application requesting approval for biosimilar version of  Rhfsh, follitropin alfa. The filing is likely to be from Finox Biotech (swiss based), which in June 2012 completed Phase 3 study on its biosimilar copy of Rhfsh, follitropin alfa (Afolia). In the Phase 3 study  Afolia demonstrated clinical and statistical equivalence to the reference product, Gonal-F (follitropin alfa). Gonal-F is a formulation of the naturally occurring hormone Follicle Stimulating Hormone (FSH),  and  is used as a fertility medication by women who have not been able to become pregnant as a result of problems with ovulation.

The results proved that Afolia is ‘biosimilar’ to Gonal-F: the number of oocytes retrieved were 11.3 in the Afolia 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. The pre-defined equivalence margin was met.

Afolia is administered through a injector pen (single use) disposable device. Thus it is free from the complications of a multi use pen. Besides the self injection process is reduced to only three steps improving patient convenience.

In the US as well, Finox will conduct a Phase 3 trial (FIN3002) for an NDA filing.

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