A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

Rettenbacher, Manfred; Andersen, Anders Nyboe; Garcia-Velasco, Juan A.; Sator, Michael; Barri, Pedro N.; Lindenberg, Svend; Ven, Katrin van der; Khalaf, Yacoub; Bentin-Ley, Ursula; Obruca, A.; Tews, G; Schenk, Michael; Strowitzki, T.; Narvekar, Nitish; Sator, K.; Imthurn, Bruno

doi:10.1016/j.rbmo.2015.01.005

Cited by 60 publications

(87 citation statements)

References 19 publications

(24 reference statements)

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“…No difference in severe OHSS was observed between treatment groups (Bemfola: 0.8 %; Gonal-f: 0.8 %). This study demonstrated similar clinical efficacy and safety profiles between Bemfola and Gonal-F, and suggests that Biosimilars can be an appropriate alternative in ovarian stimulation protocols [8].…”

Section: Discussionsupporting

confidence: 53%

“…The LH hypothesis changed worldwide thinking and the direction of stimulation protocols in ART. ''Pure'' FSH preparations with reduced LH content such as Purified FSH (PoFSH) [5], Highly Purified FSH (PoFSH-HP) [6], Recombinant FSH (recFSH) [7], and Biosimilar recFSH [8] were introduced over the last three decades into clinical practice. There was no consensus reached on the superiority of one preparation over the other till date [9][10][11].…”

Section: Discussionmentioning

confidence: 99%

“…A randomized, multicenter, Phase 3 study in women undergoing IVF or intracytoplasmic sperm injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-F [8]. No difference in severe OHSS was observed between treatment groups (Bemfola: 0.8 %; Gonal-f: 0.8 %).…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

The Ideal Stimulation Protocol: Is There One?

Allahbadia

2015

J Obstet Gynecol India

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

The Ideal Stimulation Protocol: Is There One?

Allahbadia

2015

J Obstet Gynecol India

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“…Clinical efficacy was demonstrated in an assessor-blinded, randomized, parallel-group, multicenter, phase III study conducted in women undergoing assisted reproduction techniques at 15 centers in six European countries 6. Clinical equivalence of biosimilar follitropin alfa to the originator product was demonstrated in terms of the number of oocytes retrieved during stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technology (ART) with a between-treatment group difference of 0.27 (95% CI: −1.34 to 1.32).…”

Section: Introductionmentioning

confidence: 99%

A cost-effectiveness evaluation comparing originator follitropin alfa to the biosimilar for the treatment of infertility

Gizzo¹,

García-Velasco²,

Heiman³

et al. 2016

IJWH

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ObjectivesTo perform a cost-effectiveness evaluation comparing the originator follitropin alfa (Gonal-f®) to the biosimilar (Bemfola®) in the Italian and Spanish contexts, with an assessment of the German and UK backgrounds.MethodsStarting from the study by Rettenbacher et al, a cost-effectiveness model was developed in the Italian and Spanish contexts. Clinical data on subjects, doses of gonadotropin, pregnancies, live-born children, and ovarian hyperstimulation syndrome were used to feed the model. Costs related to drugs, hospitalizations, specialist visits, and examinations were retrieved from Italian and Spanish tariffs. Gonadotropin acquisition costs for Germany and the UK were also taken into account to expand the economical assessment to the other countries. The evaluation was done based on the National Health Service perspective. Sensitivity analyses, both univariate and probabilistic, as long as scenario analyses, tested the robustness of the model.ResultsOriginator follicle-stimulating hormone (FSH) costs were €3,663 and €6,387 in Italy and Spain, respectively, whereas biosimilar FSH costs were €3,483 and €6,342. The efficacy was found to be 0.52 for the originator and 0.47 for the biosimilar. The average cost per live birth was estimated to be €7,044 and €12,283 for the originator FSH and €7,411 and €13,494 for the biosimilar for Italy and Spain, respectively. Furthermore, the originator FSH generated an incremental cost-effectiveness ratio of €3,600 for Italy and €900 for Spain compared to the biosimilar. Sensitivity analyses confirmed the results of the base case model.ConclusionThis analysis indicated that the originator FSH is a cost-efficient treatment strategy for Italian and Spanish health services compared to the biosimilar and it would be worthwhile extending this evaluation to other countries.

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“…A margin of plus or minus three oocytes to demonstrate equivalence between two FSH products has been accepted by the European Medicines Agency as it represents an end-point of clinical relevance (European Medicines Agency, 2013;Rettenbacher et al, 2015) and is tighter than that used to register a modified rhFSH with a longer half-life (−3, +5) (Devroey et al, 2009).…”

Section: Sample Sizementioning

confidence: 99%

Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation

Behre¹,

Howles²,

Longobardi

2015

Reproductive BioMedicine Online

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In this open-label study, women aged 36-40 years undergoing ovarian stimulation were randomized to recombinant human FSH (rhFSH) plus recombinant human luteinizing hormone (rhLH) from stimulation day 1 (group A; n = 103), or rhFSH alone (days 1-5) followed by rhFSH plus rhLH from day 6 (group B; n = 99). The primary objective was equivalence in number of oocytes retrieved per patient. The mean (±SD) number of oocytes retrieved was 9.7 (±6.9) in group A and 10.9 (±6.5) in group B; the estimated difference between groups (-1.28 oocytes [95% confidence interval: -3.15 to 0.59]) did not reach the predefined limit of equivalence (±3 oocytes). The study's primary objective was therefore not met. In both groups, a mean (±SD) of 1.9 (±0.6) embryos were transferred per patient. Implantation rates were 24.7% in group A and 13.3% in group B. Clinical pregnancy rates per started cycle and per embryo transfer were 31.6% and 34.4% in Group A, 17.2% and 18.9% in Group B. Ovarian hyperstimulation syndrome was reported in four (group A) and five (group B) patients. The potential benefit of initiating LH supplementation earlier during ovarian stimulation in older women is of interest, warranting further exploration.

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A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

Cited by 60 publications

References 19 publications

The Ideal Stimulation Protocol: Is There One?

The Ideal Stimulation Protocol: Is There One?

A cost-effectiveness evaluation comparing originator follitropin alfa to the biosimilar for the treatment of infertility

Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation

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