Comparison of Gonal-f® and Biosimilars in ART

In comparison to biosimilars, Gonal-f® (originator follitropin) medication may lead to greater pregnancy rates and live birth rate (LBR), says an article published in the Journal of Human Reproductive Science.

The therapeutic choices for assisted reproductive technology (ART) have expanded thanks to biosimilar medications. To improve the body of evidence for clinical decision-making on drug choice, real-world data comparing the clinical outcomes of the original follitropin alfa (Gonal-f®) with its biosimilars are needed. In order to assess the results of ART in patients receiving the original follitropin (Gonal-f®) and its biosimilars in a clinical context, Nayana Hitesh Patel and colleagues undertook this study.

Study Overview

Retrospective analysis was done on the medical records of 364 infertile women who received ART at Akanksha Hospital and Research Institute in Gujrat, India, between 2016 and 2020. Each cohort was then separated into group A (age < 35 years) and group B (age ≥ 35 years) depending on the therapy given to the participants (Gonal-f® cohort, N = 174, and biosimilar cohort, N = 190). Transfer of fresh or frozen embryos was done in accordance with the clinic's established protocols. The key main outcome indicators in this study were the prevalence of pregnancy and the live birth rate. Analyses were conducted using descriptive statistics and the Chi-square test.

Key Findings

• Comparable numbers of oocytes (13.3 vs. 14.4) were recovered from the Gonal-f® and biosimilar groups.
• The Gonal-f® therapy produced more cleavage stage and blastocyst stage embryos than biosimilars did, and a larger percentage of women in the Gonal-f® cohort had excellent quality embryos than in the biosimilar cohort (83.3% vs. 69.5%).
• When compared to patients receiving biosimilars, those receiving Gonal-f® saw greater rates of pregnancy (59.2% vs. 39.7%) and LBR (43% vs. 17.7%).

Conclusion

The findings of this study demonstrate that, in a real-world scenario, patients receiving Gonal-f® have higher pregnancy rates and LBR than those receiving biosimilars. To assist doctors and patients in selecting follitropin alpha in ART, real-world research contrasting the two FSH preparations should be conducted.

Reference

Patel, N., Patel, N., Patel, M., Bhadarka, H., & Vyas, K. (2023). Clinical outcomes in patients receiving originator follitropin alfa and follitropin alfa biosimilars in real-world clinical practice: A retrospective study. In Journal of Human Reproductive Sciences (Vol. 16, Issue 2, p. 148). Medknow. https://doi.org/10.4103/jhrs.jhrs_37_23