Green Light for FINOX’s Biosimilar

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, a biosimilar follicle stimulating hormone used for the treatment of infertility, could be available in the EU in the second quarter of 2014.

To date, nearly 400 patients have received at least one dose of BEMFOLAin Phase I or III studies. The MAA for BEMFOLAis supported primarily by data from one Phase III study, in which BEMFOLAtherapy 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”.

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 Swissengineered state-of–the-art delivery device”.

About BEMFOLA
BEMFOLAwas produced using recombinant DNA technology. Both BEMFOLAand the reference product GONAL-fare formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. BEMFOLAis 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 BEMFOLAPen, is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject. Accordingly the BEMFOLAPen won a ‘Red-Dot’ design award as an indication of just how successfully it fulfils its brief.

About FINOX Biotech
FINOX Biotech (FINOX AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. FINOX Biotech was founded in 2007 with a vision to become a leading company in the field of fertility therapies, by combining high quality Swiss medicines with innovative, award-winning delivery devices.