References
- Ledford H. ‘Biosimilar’ drugs poised to penetrate market. Nature. 2010 Nov 4;468(7320):18–19. PMID: 21048737.
- Ben-Maimon CS. Point: why biogenerics make sense. Nat Biotechnol. 2006 Mar;24(3):268–269. PMID: 16525381.
- medicinesforeurope.com [Internet]. IMS Institute; [cited 2019 May 03]. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf
- ema.europa.eu [Internet]. European Medicines Agency. EPAR summary for the public: GONAL-f. [cited 2019 Feb 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/000071/WC500023742.pdf
- ema.europa.eu [Internet]. European Medicines Agency. EPAR summary for the public: BEMFOLA. [cited 2019 Feb 26]. https://www.ema.europa.eu/en/documents/assessment-report/bemfola-epar-public-assessment-report_en.pdf
- ema.europa.eu [Internet]. European Medicines Agency. EPAR summary for the public: OVALEAP. [cited 2019 Feb 26]. https://www.ema.europa.eu/en/documents/overview/ovaleap-epar-summary-public_en.pdf
- Barakhoeva Z, Vovk L, Fetisova Y, et al. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6–12. Epub 2019 Jul 26. PMID: 31400644.
- Iqvia.com [Internet]. Advancing Biosimilar Sustainability in Europe; [cited 2019 Sep 10] https://www.iqvia.com/insights/the-iqvia-institute/reports/advancing-biosimilar-sustainability-in-europe
- Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: an overview. PLoS ONE. 2017;12(12):e0190147.
- Iqvia.com [Internet]. Advancing Biosimilar Sustainability in Europe; [cited 2019 Sep 10]. Available from: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjiiJGJ-_juAhUJyqQKHfA4CKoQFjABegQIARAD&url=https%3A%2F%2Fec.europa.eu%2Fdocsroom%2Fdocuments%2F31642%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fnative&usg=AOvVaw29beGo7y5l0rDapUeBqsuL
- medicinesforeurope.com [Internet]. IMS Institute; [cited 2019 May 03]. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Impact-of-Biosimilar-Competition-2015.pdf
- medicinesforeurope.com [Internet]. IMS Institute; [cited 2019 May 03]. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/08/IMS-Impact-of-Biosimilar-Competition-2016.pdf
- medicinesforeurope.com [Internet]. IMS Institute; [cited 2019 May 03]. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf
- Iqvia.com [Internet]. Advancing Biosimilar Sustainability in Europe; [cited 2019 Sep 10] Available from: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi9-vah-_juAhXC-aQKHddaB30QFjACegQIARAD&url=https%3A%2F%2Fec.europa.eu%2Fhealth%2Fsites%2Fhealth%2Ffiles%2Fhuman-use%2Fdocs%2Fbiosimilar_competition_en.pdf&usg=AOvVaw05aVyLl2qhCtBRLfUHj-o6
- Young KE, Rémuzat C, Urbinati D, et al. Boosting biosimilars uptake in European countries. Value Health. 2014 Nov;17(7):A408–9. Epub 2014 Oct 26. PMID: 27200994.
- Gizzo S, Garcia-Velasco JA, Heiman F, et al. A cost-effectiveness evaluation comparing originator follitropin alfa to the biosimilar for the treatment of infertility. Int J Womens Health. 2016 Dec 7;8:683–689.
- Gizzo S, Ferrando M, Lispi M, et al. A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany, Italy and Spain. J Med Econ. 2018 Nov;21(11):1096–1101. Epub 2018 Aug 31. PMID: 30113238.
- Grynberg M, Murphy C, Doré C, et al. A cost-effectiveness analysis comparing the originator follitropin alpha to its biosimilars in patients undergoing a medically assisted reproduction program from a French perspective. J Med Econ. 2018;22(1):108–115.
- Xue W, Lloyd A, Falla E, et al. A cost-effectiveness evaluation of the originator follitropin alpha compared to the biosimilars for assisted reproduction in Germany. Int J Womens Health. 2019 May 13;11:319–331.
- Silverio N, Botica F, Batista A. Cost-effectiveness of recombinant human follicle stimulating hormone biosimilars in Portugal [abstract]. Value Health. 2016;19(7):A402–A403.
- Silverio N, Botica F, Batista A. Cost-effectiveness of recombinant human follicle stimulating hormone biosimilars in Portugal. ISPOR 19th Annual European Congress; 2016 October 29–November 02; Vienna, Austria. PIH18.
- Silverio N, Batista AR, Sequeira L. Biosimilars, are they really cost saving? The case of recombinant human follicle stimulating hormone in Portugal [abstract]. Value Health. 2015;18(7):A736.
- Strowitzki T, Kuczynski W, Mueller A, et al. Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle stimulating hormone) in infertile women using assisted reproduction technology (ART). Reprod Biol Endocrin. 2016;14:1.
- Rettenbacher M, Andersen AN, Garcia-Velasco AJ, et al. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015;30(5):504–513.
- The Harbin Consensus Conference, Workshop Group. Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement. Hum Reprod. 2014;29:1995–2005.
- Claus BO, Simoens S, Vanhorebeek S, et al. Budget impact analysis of the introduction of biosimilars in a Belgian tertiary care hospital: a simulation [abstract]. Value Health. 2016;19(7):PA460.
- Fasola G, Aprile G, Marini L, et al. Drug waste minimization as an effective strategy of cost-containment in oncology. BMC Health Serv Res. 2014;15:57.
- Foxon G, Mitchell P, Turner N, et al. Bemfola fixed dose pens potentially reduce drug wastage and associated costs of infertility treatment. Hum Fertil. 2018;21(4):275–280.
- Bergandi L, Canosa S, Carosso AR, et al. Human recombinant FSH and its biosimilars: clinical efficacy, safety, and cost-effectiveness in controlled ovarian stimulation for in vitro fertilization. Pharmaceuticals (Basel). 2020 Jun 27;13(7):136. PMID: 32605133; PMCID: PMC7407829.
- Remuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017;5(1):1–15.
- Christianson M, Shoham G, Tobler KJ, et al. Use of various gonadotropin and biosimilar formulations for in vitro fertilization cycles: results of a worldwide Web-based survey. J Assist Reprod Genet. 2017;34:1059–1066.
- Hallersten A, Furst W, Mezzasalma R. Physicians prefer greater detail in the biosimilar label (SmPC) – results of a survey across seven European countries. Regul Toxicol Pharmacol. 2016;77:275–281.
- Imthurn B, McVeigh E, Stiller R, et al. Rettenbacher M. Evaluation of the use and handling of three different pen systems considered for in vitro fertilization treatment. Expert Opin Drug Deliv. 2014;11(12):1859–1864.
- Zitoun P, Parikh J, Nijs M, et al. Analysis of patient and nurse preferences for self-administered FSH injection devices in select European markets. Int J Womens Health. 2019;11:11–21.
- Strowitzki T, Kuczynski W, Mueller A, et al. Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study. Reprod Biol Endocrin. 2016;14(1):31.