Ovaleap (follitropin alfa biosimilar) / Teva - LARVOL DELTA

Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (clinicaltrials.gov) - P=N/A | N=190 | Completed | Sponsor: Peter Kovacs MD | Recruiting ➔ Completed | N=700 ➔ 190

Enrollment change • Trial completion • Infertility • Sexual Disorders

Clinical outcomes of three follitropin alfa preparations for ovarian stimulation using an oral micronized progesterone-primed protocol in an oocyte donation program. (PubMed, Front Endocrinol (Lausanne)) - "This large multicenter study aimed to evaluate clinical outcomes using three follitropin alfa preparations within a progestin-primed ovarian stimulation (PPOS) protocol, while identifying contributing factors to cycle success. No significant differences were observed in the cumulative live birth rate (CLBR) among oocytes obtained from stimulation with Bemfola (64.9%), Gonal-F (64.1%) and Ovaleap (66.1%), p= 0.385. This study demonstrated comparable clinical outcomes and CLBR between biosimilars and the reference product of follitropin alfa within PPOS protocols, hence they are interchangeable in a real-world patient setting."

Clinical • Clinical data • Journal • Retrospective data

Determining the effects of follicle stimulating hormone (FSH) biosimilars on immunogenic and angiogenic responses of human granulosa lutein cells (Fertility 2023) - "hGLs were cultured for 5 days before stimulation -/+ 10ng/ml Gonal F (originator), Bemfola or Ovaleap (biosimilars) for 0, 8, 24,48-hours. r-hFSH preparations modulate the expression and secretion of cytokines and VEGF in hGLs, with potential distinct regulation of VEGF. This has implications for r-hFSHpreparation-specific regulation of granulosa cell functions."

Endometriosis • Gynecology • Women's Health • CXCL8 • IL6

E-Poster Abstract Station: W06 (ASRM 2022) - "OBJECTIVE: To assess clinical outcomes using different follitropin alfa preparations in the context of a progestin primed ovarian stimulation (PPOS) protocol and to identify confounding factors attributable to the success of the cycle MATERIALS AND Women accepted as oocyte donors and undergoing ovarian stimulation with 3 different follitropin alfa preparations Ovaleap® (Theramex Spain); n=3231, Bemfola® (Gedeon Richter Iberica); n=3542 or Gonal-F® (Merck SL) n=616...On the first FSH stimulation day, 10 mg acetate of medroxyprogesterone (MPA) was administered daily and then continued until GnRH agonist trigger (triptorelin)... As biosimilars have minor variations in sialylation from the originator, it is very reassuring that these small differences had no clinical impact when compared with the reference product. The different types of follitropin alfa are interchangeable in PPOS. IMPACT STATEMENT: No differences were found between different types of..."

Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (clinicaltrials.gov) - P=N/A | N=700 | Recruiting | Sponsor: Peter Kovacs MD | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

Overlapping biosimilar and originator follitropin alfa preparations: how much closer can they get? (PubMed, Drug Discov Today) - "Accordingly, the minor differences in 'ongoing pregnancy rate' and 'live birth' rate reported in a recent meta-analysis of biosimilars and Gonal-f® are probably driven by product-unrelated factors, notwithstanding the fact that of the four products under analysis, only Ovaleap® (from Theramex) and Bemfola® (from Gedeon Richter Plc) can unambiguously be considered to be biosimilars. The EU biosimilars model has proven successful, but given the distrust in biosimilars that is built on a biased foundation, the full promise of rFSH alfa biosimilars for reproductive medicine patients is unlikely to be fulfilled {AuQ: Edit OK?}. Teaser: {AuQ: Please provide the missing teaser.}."

Journal

Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (clinicaltrials.gov) - P=N/A; N=700; Not yet recruiting; Sponsor: Peter Kovacs MD

Clinical • New trial • Infertility • Sexual Disorders

Follitropin alpha versus beta in a first GnRH antagonist ICSI cycle: a retrospective cohort study. (PubMed, Reprod Biomed Online) - "This retrospective study shows no significant difference in CLBR between Ovaleap and Puregon in patients undergoing their first GnRH antagonist ICSI cycle."

Journal • Retrospective data • Infertility

[VIRTUAL] Effectiveness of Ovaleap® compared to Gonal-f® for ovarian stimulation in real-world clinical practice: Results from a multi-national European prospective (SOFIA) study (Fertility 2021) - "Findings from the SOFIA study indicate that pregnancy and delivery rates were similar between Ovaleap® and Gonal-f® treatments and further corroborate the effectiveness of Ovaleap® as a biosimilar to Gonal-f®"

Clinical • Real-world evidence • Infertility

[VIRTUAL] Safety of Ovaleap® compared to Gonal-f® in real-world clinical practice: Results from the safety of Ovaleap® follitropin alfa (SOFIA) study (Fertility 2021) - "Findings from SOFIA study indicate that the risk of OHSS and OHSS severity were similar between Ovaleap® and Gonal-f® treatments and further corroborate the safety of Ovaleap® as a biosimilar to Gonal-f®."

Clinical • Real-world evidence • Infertility

INTEnsity of ovariaN Stimulation and Embryo Quality Intensidad de la estimulación ovárica y calidad embrionaria (clinicaltrialsregister.eu) - P4; N=100; Ongoing; Sponsor: Fundacion Santiago Dexeus Font

Clinical • New P4 trial • Infertility

A large observational data study supporting the PROsPeR score classification in poor ovarian responders according to live birth outcome. (PubMed, Hum Reprod) - "C.A., J.P., G.P. and R.W. declare no conflict of interest. N/A."

Clinical • Journal • Observational data • Infertility • Sexual Disorders

Safety of Ovaleap® (Follitropin Alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies: A Multinational Comparative, Prospective Cohort Study. (PubMed, Front Endocrinol (Lausanne)) - "Among patients who had embryo transfer, clinical pregnancy rates were 33% and 31% and live birth rates were 27% and 26%, in the two cohorts, respectively. Findings from the SOFIA study indicate that the incidence proportions of OHSS and OHSS severity, as well as pregnancy and live birth rates, are similar between Ovaleap and Gonal-f treatments and corroborate the safety and effectiveness of Ovaleap as a biosimilar to Gonal-f."

Clinical • Journal • Infertility

The pharmacoeconomic impact of follitropin alpha biosimilars in IVF therapy in Europe: a report of the literature. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "In assisted reproductive treatments different gonadotropin biosimilars are being produced.Areas covered: For this reason, we performed a review of the literature on follitropin alfa Gonal-F biosimilar, Ovaleap and Bemfola, to assess their cost efficacy in national health system. In particular, they had only slight impact on cost reduction of recombinant follitropin alfa products in Europe.Expert opinion: considering cost-effective analysis, Gonal-F remains the first choice for national health systems. However, well-designed powered methods are strongly needed to assess biosimilars cost-effectiveness."

HEOR • Journal

Retrospective analysis of the use of two recombinant follitropin alfa injections in patients undergoing in vitro fertilization treatment with the gonadotropin-releasing hormone antagonist protocol. (PubMed, J Obstet Gynaecol Res) - "While the clinical efficacy profile favored using Gonal-f formulation of follitropin alfa, this analysis showed that there is no significant difference in the number of oocytes retrieved between Ovaleap and Gonal-f follitropin alfa formulations, used within GnRH antagonist protocols of COH."

Journal • Retrospective data • Gynecology • Infertility • Sexual Disorders

Risk of dosing errors in ART treatment: user experience of single- vs multi-use follitropin alfa pens. (PubMed, Expert Opin Drug Deliv) - ": Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors."

Journal • Gynecology • Infertility • Sexual Disorders

A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen. (clinicaltrials.gov) - P=N/A; N=507; Completed; Sponsor: Teva Pharma GmbH; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Mar 2018; Trial primary completion date: Sep 2018 ➔ Jul 2017

Trial completion • Trial completion date • Trial primary completion date • Biosimilar

Effectiveness and safety of follitropin alfa (Ovaleap®) for ovarian stimulation using a GnRH antagonist protocol in real-world clinical practice: a multicenter, prospective, open, non-interventional assisted reproductive technology study. (PubMed, Reprod Biol Endocrinol) - P=N/A | "The effectiveness and safety of OS with Ovaleap® in a GnRH antagonist protocol were extended to real-world ART clinical practice for the first time."

Clinical • Journal • Real-World Evidence • Sexual Disorders

An evaluation of the use and handling errors of currently available recombinant human follicle-stimulating hormone pen injectors by women with infertility and fertility nurses. (PubMed, Expert Opin Drug Deliv) - "Background: This study compared preference ratings of women with infertility and nurses before and after simulated injection, and handling errors, with the GONAL-f®, Bemfola®, Ovaleap® and Rekovelle® pen injectors...Adjusted rates of total handling errors were lower with the GONAL-f vs other injectors (p < 0.001 for all comparisons) for both groups. GONAL-f injector was rated significantly higher than other injectors, which may be related to less handling errors observed with the GONAL-f injector."

Clinical • Journal

Performance of prognostic modelling of high and low ovarian response to ovarian stimulation for IVF. (PubMed, Hum Reprod) - "has received personal fees and non-financial support from MSD, Ferring, Merck-Serono, Finox, TEVA, IBSA, Glycotope, Abbott, Marckryl Pharma, VitroLife, NMC Healthcare, ReprodWissen, ZIVA and BioSilu. Not applicable."

Journal

RE: A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany, Italy and Spain. (PubMed, J Med Econ) - No abstract available.

HEOR • Journal

Reply: RE: A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany, Italy and Spain. (PubMed, J Med Econ) - No abstract available.

HEOR • Journal

Glycosylation Pattern and in vitro Bioactivity of Reference Follitropin alfa and Biosimilars. (PubMed, Front Endocrinol (Lausanne)) - "The aim of the study is to compare the originator (reference) follitropin alfa (Gonal-f®)- with biosimilar preparations (Bemfola® and Ovaleap®)-induced cellular responses in vitro. All preparations induced both 8 and 24 h-progesterone and estradiol synthesis in hGLC, while no different ECs were demonstrated (Kruskal-Wallis test; p > 0.05; n = 5). Apart from preparation-specific intracellular Ca increases achieved at supra-physiological hormone doses, all compounds induced similar intracellular responses and steroidogenesis, reflecting similar bioactivity, and overall structural homogeneity."

Journal • Preclinical

A systematic review and meta-analysis comparing Biosimilar versus Originator Recombinant Follitropin Alfa in women undergoing IVF/ICSI (ESHRE 2019) - P3; "The biosimilar preparations were Bemfola in two studies and Ovaleap in one study. In addition, women with history of severe OHSS were excluded from the trials. Wider implications of the findings: In published RCTs in women undergoing IVF, ovarian stimulation with biosimilar follitropin alfa reduced the chances of live birth by 18% compared with the originator preparation."

Retrospective data • Review

A cost-effectiveness evaluation of the originator follitropin alpha compared to the biosimilars for assisted reproduction in Germany. (PubMed, Int J Womens Health) - "The objective of this study was to evaluate the cost-effectiveness of the recombinant FSH Gonal-f (Originator) in comparison to biosimilar follitropin alfa, Bemfola (Biosimilar 1) and Ovaleap (Biosimilar 2), from a German payer perspective in terms of cost per live birth. This study suggests that treatment with the Originator could result in a lower cost per live birth in comparison to biosimilars. Further analysis using real-world data, when available, is recommended to validate the results of the present study."

HEOR • Journal