BEMFOLA (recombinant follitropin alfa), gonadotropin
GYNAECOLOGY AND OBSTETRICS - New medicinal product
Opinions on drugs - Posted on Mar 06 2015
Reason for request
As a biosimilar medicine, BEMFOLA provides no demonstrated clinical benefit when compared with GONAL-F, the standard biological product.
- BEMFOLA is a biosimilar of GONAL-F. It has Marketing Authorisation in the stimulation of follicle growth and spermatogenesis (see the indications below)
- The clinical equivalence of BEMFOLA and GONAL-F has been demonstrated in a study relating to the stimulation of multifollicular development in women undergoing superovulation for assisted
Improvement in actual benefit