Finox Biotech announced yesterday that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application for BEMFOLA (follitropin alfa solution for injection in pre-filled pens), a biosimilar follicle stimulating hormone used for the treatment of infertility.
The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU). If approved, BEMFOLA could be available in the EU in the second quarter of 2014.
To date, nearly 400 patients have received at least one dose of BEMFOLA in Phase I or III studies. The MAA for BEMFOLA is supported primarily by data from one Phase III study, 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 this Phase III study, similar efficacy and safety profiles were observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.
Gavin Jelic-Masterton, CEO of Finox Biotech commented, “We are thrilled 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”.
Dr. h.c. Willy Michel, President of the Board of Finox Biotech added, “Finox Biotech have done extraordinarily well in bringing a recombinant protein to a CHMP positive opinion in the European Union. 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”.
Source: Finox Biotech press release