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BEMFOLA (recombinant follitropin alfa), gonadotropin

GYNAECOLOGY AND OBSTETRICS - New medicinal product
Opinions on drugs - Posted on Mar 06 2015

Reason for request

Inclusion

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
    reproductive technologies.

Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-