The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the 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 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.”
Bemfola was produced using recombinant DNA technology. Both Bemfola and the reference product GONAL-f are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. Bemfola is the result of a targeted drug development process aimed to replicate as closely as possible the reference product. The brief to the development engineers when designing the Bemfola injector device was to produce a Pen that absolutely minimised the number of steps a patient needs to take when preparing the injection and to ensure that the patient and physician had maximum control and the least chance of a patient error. The result, the Bemfola Pen, is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject. Accordingly the Bemfola Pen won a ‘Red-Dot’ design award as an indication of just how successfully it fulfils its brief.
Finox Biotech has agreed with the US-FDA to conduct a pivotal phase III study (FIN3002) for registration of Bemfola (AFOLIA) in the USA. A US-IND has been opened and the FIN3002 study is now in progress.
Finox Biotech (Finox AG) is a biopharmaceutical company aims to become a leading company in the field of fertility therapies, by combining high quality Swiss medicines with innovative, award-winning delivery devices.