FINOX Biotech has submitted the Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) BEMFOLA to the European Medicines Agency.
The submission was based on a comprehensive clinical development program, in which BEMFOLA had shown to be statistically equivalent to the reference product in patients participating in an Assisted Reproductive Technology (ART) pivotal phase 3 clinical trial.
FINOX Biotech chief executive officer Anjan Selz said the recent eCTD submission represents five years of concentrated development efforts.
''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," Selz added.
