LIVE BIRTH RATE (LBR), ONGOING PREGNANCY RATE (OPR) AND OVARIAN HYPERSTIMULATION SYNDROME (OHSS) RISK WITH ORIGINATOR VERSUS BIOSIMILAR RECOMBINANT FOLLITROPIN ALFA- A POOLED ANALYSIS OF CLINICAL TRIAL DATA
Author(s)
Papsch R, Roeder C, D'Hooghe T, Longobardi S
Merck KGaA, Darmstadt, Germany
Presentation Documents
OBJECTIVES: To investigate whether LBR, OPR and OHSS, and the benefit-risk balance of these outcomes, differ between originator and biosimilar recombinant human follicle-stimulating hormone preparations. METHODS: Pooled analysis of Phase III clinical trial data for Ovaleap® and Bemfola® versus GONAL-f® RESULTS: Data were included for 269 patients who received originator and 402 patients who received biosimilars (Ovaleap, 153; Bemfola, 249). The maximum likelihood estimate (standard error) and p-value were: 0.3105 (0.1699), p=0.0338 for LBR per patient; 0.3019 (0.1686), p=0.0367 for OPR per patient; and –0.9916 (0.4323), p=0.0109 for OHSS incidence. Differences between originator and biosimilars were independent of the study (Ovaleap or Bemfola). These results show that different outcomes were observed with originator compared with biosimilars and suggest that there may be improved outcomes (greater likelihood of LBR and OPR) with less risk of OHSS if originator is used instead of a biosimilar preparation. Evaluation of individual studies confirmed this finding. CONCLUSIONS: This pooled analysis highlights that biosimilar preparations are not identical to the originator preparation, and suggests that the benefit-risk balance, based on LBR, OPR and OHSS incidence, is better with the originator preparation. Prospective clinical trials and/or analysis of real-world data powered to compare the LBR, OPR and OHSS risk with all the available products are required to support these findings.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PMU40
Topic
Economic Evaluation
Topic Subcategory
Cost-comparison, Effectiveness, Utility, Benefit Analysis
Disease
Multiple Diseases