The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on FINOX Biotech's marketing authorisation application (MAA) for BEMFOLA (follitropin alfa solution for injection in pre-filled pens), a biosimilar follicle stimulating hormone used for the treatment of infertility.
The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the EU and if approved, the drug will be available in the EU in the second quarter of 2014.
So far, about 400 patients have received at least one dose of BEMFOLA in Phase I or III trials.
The MAA is supported primarily by data from one Phase III trial, in which BEMFOLA therapy was found to be similar to the currently available treatment with GONAL-f, based on the numbers of oocytes retrieved after completing FSH therapy.
In the Phase III trial, similar efficacy and safety profiles were seen between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.
FINOX Biotech CEO Gavin Jelic-Masterton said the company is happy that the CHMP has given a positive opinion for BEMFOLA.
"This is a great achievement for FINOX Biotech and for our investors. We can now look forward to offering IVF Specialists and patients more choice in their product and delivery system," Jelic-Masterton said.
FINOX Biotech Willy president of the Board Michel said the company has done extraordinarily well in bringing a recombinant protein to a CHMP positive opinion in the EU.
"This demonstrates the commitment of the team to delivering a high quality medicine that will use a Swiss-engineered state-of-the-art delivery device," Michel added.
The company said that both BEMFOLA and the reference product GONAL-f are formulations of the naturally occurring hormone FSH, which plays a major role in human reproduction.
