THE NOVEL BIOSIMILAR OF FOLLITROPIN ALPHA TO BE MANUFACTURED IN RUSSIA STARTING FROM 2017

Abstract

Within the framework of the 27th international conference «Reproductive technologies today and tomorrow», the first Russia-made follitropin alfa biosimilar for controlled ovarian stimulation in assisted reproductive technologies (ART) was presented. The follicle-stimulating hormone (FSH) biosimilar has undergone  all stages  of development in Russia, from the producer cells culture to the release of active FSH. Also the data are presented  on a prospective randomized crossover study of phase I  confirming the similarity of pharmacokinetics between the biosimilar and the original FSH. Another randomized multicenter phase III clinical study is now under way aiming to demonstrate the clinical equivalence between the biosimilar and the original FSH; preliminary  results  of this study are presented and discussed. As planned, the recombinant FSH biosimilar will be produced in disposable injectors (pen-injector) that provide easy-to-use handling, convenient dose setting and wide range dosing.