In a nutshell
This study examined whether bemfola has a similar safety and effectiveness profile as Gonal-f in women undergoing assisted reproductive technology.
Follicle-stimulating hormone (FSH) is a female hormone which is involved in the development of eggs in the ovaries. Gonal-f (follitropin alfa) is a drug which acts in a similar manner to FSH and is used to stimulate the ovaries during in vitro fertilization (IVF; the sperm fertilizes the egg in a laboratory dish outside the body, and doctors implant it into the woman's uterus) or intracytoplasmic sperm injection (ICSI, when a single sperm is injected directly into the egg priorto IVF).
However, Gonal-f is quite expensive and biosimilar drugs (drugs which have the same effect) have been developed as a cheaper alternative. Bemfola is biosimilar to Gonal-f and the injection device can only be used once single rather than multiple times. It is believed that Bemfola may have a similar safety and effectiveness profile as Gonal-f.
Methods & findings
This study aimed to compare the safety and effectiveness of Bemfola and Gonal-f. This study involved 372 women undergoing IVF or ICSI. Participants received an injection of a gonadotrophin-releasing hormone (GnRH, used to control timing of ovulation) agonist, followed by Bemfola or Gonal-f. 220 participants received 150 IU of Bemfola daily, while 113 received 150 IU of Gonal-f daily. After eggs were retrieved, IVF or ICSI was performed.
The average number of eggs retrieved was similar in both the Bemfola-treated group (10.8) and the Gonal-f-treated group (10.6). The average pregnancy rate per embryo transfer was similar in participants receiving Bemfola (40.2%) and Gonal-f (48.2%). There was no difference in ovarian hyperstimulation syndrome (painful, swollen ovaries, which can lead to a serious increase in fluid in the abdomen or chest) between both groups.
The bottom line
This study concluded that Bemfola was as safe and effective as Gonal-f. The authors suggest that Bemfola can be used as an alternative to Gonal-f for ovarian stimulation.
The fine print
The dose of FSH was not altered for participants that had a low pregnancy success rate.
Consult your physician regarding the availability of biosimilar Gonal-f drugs.
Published By :
Reproductive BioMedicine Online
May 01, 2015