Finox Biotech, a biopharmaceutical company, has submitted the Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) to the European Medicines Agency (EMA) on October 30, 2012.

The submission of the MAA is a major milestone for Finox Biotech and its lead-product r-FSH BEMFOLA (development code “AFOLIA”). The BEMFOLA MAA was based on a comprehensive clinical development programme in which BEMFOLA was demonstrated to be statistically equivalent to the reference product in patients participating in an Assisted Reproductive Technology (ART) pivotal phase 3 clinical trial.

Anjan Selz, chief executive officer of Finox Biotech commented: "The recent eCTD submission represents five years of concentrated development efforts. I am very pleased that the very positive results obtained allowed us to achieve this important milestone. We now focus on working together with the health authorities in order to give the European ART patients access to this valuable medicine as soon as possible.”

BEMFOLA is a new “biosimilar” medicine: an almost exact copy of the originator product that 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. BEMFOLA has a number of key beneficial characteristics. i.e. equivalent clinical efficacy and safety vs. Gonal-f, but using a substantially more attractive injector device.

The BEMFOLA injector pen is a single-use, one-a-day disposable device, which presents compliance and safety advantages. The self-injection process is reduced to only three steps, which enhances ease-of-use and patient acceptance.

Finox Biotech has agreed with the US-FDA via a Special Protocol Assessment to conduct a pivotal phase III study (FIN3002) for registration of BEMFOLA (AFOLIA) in the USA. A US IND was filed and the FIN3002 study is in progress.