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ORIGINAL RESEARCH

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

ORCID Icon, , , , , , & ORCID Icon show all
Pages 1067-1076 | Received 17 Feb 2023, Accepted 28 Mar 2023, Published online: 08 Apr 2023

References

  • Veritti D, Sarao V, Lanzetta P. Neovascular age-related macular degeneration. Ophthalmologica. 2012;227(Suppl 1):11–20. doi:10.1159/000337154
  • Cheung LK, Eaton A. Age-related macular degeneration. Pharmacotherapy. 2013;33(8):838–855. doi:10.1002/phar.1264
  • Gheorghe A, Mahdi L, Musat O. Age-related macular degeneration. Rom J Ophthalmol. 2015;59(2):74–77.
  • Handa JT, Verzijl N, Matsunaga H, et al. Increase in the advanced glycation end product pentosidine in Bruch’s membrane with age. Invest Ophthalmol Vis Sci. 1999;40(3):775–779.
  • Klein R, Klein BE, Cruickshanks KJ. The prevalence of age-related maculopathy by geographic region and ethnicity. Prog Retin Eye Res. 1999;18(3):371–389. doi:10.1016/s1350-9462(98)00025-1
  • Vingerling JR, Dielemans I, Hofman A, et al. The prevalence of age-related maculopathy in the Rotterdam Study. Ophthalmology. 1995;102(2):205–210. doi:10.1016/s0161-6420(95)31034-2
  • Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106–e116. doi:10.1016/S2214-109X(13)70145-1
  • Barchitta M, Maugeri A. Association between vascular endothelial growth factor polymorphisms and age-related macular degeneration: an updated meta-analysis. Dis Markers. 2016;2016:8486406. doi:10.1155/2016/8486406
  • Veritti D, Sarao V, Soppelsa V, Danese C, Chhablani J, Lanzetta P. Managing neovascular age-related macular degeneration in clinical practice: systematic review, meta-analysis, and meta-regression. J Clin Med. 2022;11(2):325. doi:10.3390/jcm11020325
  • Ricci F, Bandello F, Navarra P, Staurenghi G, Stumpp M, Zarbin M. Neovascular age-related macular degeneration: therapeutic management and new-upcoming approaches. Int J Mol Sci. 2020;21(21):8242. doi:10.3390/ijms21218242
  • Schmidt-Erfurth U, Chong V, Loewenstein A, et al. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98(9):1144–1167. doi:10.1136/bjophthalmol-2014-305702
  • Ferrara N, Damico L, Shams N, Lowman H, Kim R. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina. 2006;26(8):859–870. doi:10.1097/01.iae.0000242842.14624.e7
  • Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419–1431. doi:10.1056/NEJMoa054481
  • Davis J, Olsen TW, Stewart M, Sternberg P Jr. How the comparison of age-related macular degeneration treatments trial results will impact clinical care. Am J Ophthalmol. 2011;152(4):509–514. doi:10.1016/j.ajo.2011.07.004
  • Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1432–1444. doi:10.1056/NEJMoa062655
  • Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol. 2008;145(2):239–248. doi:10.1016/j.ajo.2007.10.004
  • Kelkar A, Webers C, Shetty R, et al. Factors affecting compliance to intravitreal anti-vascular endothelial growth factor therapy in Indian patients with retinal vein occlusion, age-related macular degeneration, and diabetic macular edema. Indian J Ophthalmol. 2020;68(10):2143–2147. doi:10.4103/ijo.IJO_1866_19
  • Sengupta S. Current perspectives on use of anti-vascular endothelial growth factor agents for retinal disorders. Indian J Ophthalmol. 2021;69(2):209–210. doi:10.4103/ijo.IJO_72_21
  • Stewart MW, Narayanan R, Gupta V, Rosenfeld PJ, Martin DF, Chakravarthy U. Counterfeit avastin in India: punish the criminals, not the patients. Am J Ophthalmol. 2016;170:228–231. doi:10.1016/j.ajo.2016.05.023
  • Verma L, Thulasidas M, Purohit A, Gupta A, Narula R, Talwar D. Clinical efficacy and safety of Razumab® (CESAR) study: our experience with the world’s first biosimilar ranibizumab. Indian J Ophthalmol. 2021;69(2):347–351. doi:10.4103/ijo.IJO_2516_20
  • Ratra D, Roy K, Giridhar S, Madaan S; Sankara Nethralaya Vitreoretinal Study Group. Comparison between ranibizumab biosimilar, innovator ranibizumab and bevacizumab in a real-world situation. Ophthalmol Ther. 2022;11(1):135–149. doi:10.1007/s40123-021-00416-4
  • Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7(1):9–14. doi:10.4161/19420862.2015.989042
  • Griaud F, Winter A, Denefeld B, et al. Identification of multiple serine to asparagine sequence variation sites in an intended copy product of LUCENTIS® by mass spectrometry. MAbs. 2017;9(8):1337–1348. doi:10.1080/19420862.2017.1366395
  • Sheth JU, Stewart MW, Khatri M, et al. Changing trends in the use of anti-vascular endothelial growth factor (anti-VEGF) biosimilars: insights from the vitreoretinal society of India biosimilars of anti-VEGF survey. Indian J Ophthalmol. 2021;69(2):352–356. doi:10.4103/ijo.IJO_2703_20
  • Chakraborty D, Stewart MW, Sheth JU, et al. Real-world safety outcomes of intravitreal ranibizumab biosimilar (Razumab) therapy for chorioretinal diseases. Ophthalmol Ther. 2021;10(2):337–348. doi:10.1007/s40123-021-00345-2
  • Sharma S, Khan MA, Chaturvedi A; RE-ENACT Study Investigators Group. Real-life clinical effectiveness of razumab® (the world’s first biosimilar of ranibizumab) in retinal vein occlusion: a subgroup analysis of the pooled retrospective RE-ENACT study. Ophthalmologica. 2019;241(1):24–31. doi:10.1159/000488602
  • Sharma S, Gupta V, Maiti A, et al. Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study. Int J Retin Vitr. 2021;7(1):24. doi:10.1186/s40942-021-00293-w
  • Sharma A, Kumar N, Parachuri N, Bandello F, Kuppermann BD, Loewenstein A. Ranibizumab biosimilar (Razumab) vs innovator ranibizumab (Lucentis) in neovascular age-related macular degeneration (n-AMD)- efficacy and safety (BIRA study). Eye. 2022;36(5):1106–1107. doi:10.1038/s41433-021-01616-9
  • Sameera VV, Apoorva AG, Joshi S, Guruprasad AS. Safety and efficacy of Razumab - the new biosimilar in India: our experience. Kerala J Ophthalmol. 2016;28:180. doi:10.4103/kjo.kjo_18_17
  • Sharma S, Khan MA, Chaturvedi A; RE-ENACT Study Investigators Group. Real life clinical effectiveness of Razumab® (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a subgroup analysis of pooled retrospective RE-ENACT study. Int J Ophthalmol Eye Sci. 2018;6:368–373.
  • Chakraborty D, Sengupta S, Mondal S, et al. Comparison of innovator vs. biosimilar ranibizumab in treating diabetic macular edema: a multicenter retrospective study. Ophthalmol Ther. 2022;11(2):629–638. doi:10.1007/s40123-022-00463-5
  • Hatz K, Prünte C. Treat and extend versus pro re nata regimens of ranibizumab in neovascular age-related macular degeneration: a comparative 12 month study. Acta Ophthalmol. 2017;95(1):e67–e72. doi:10.1111/aos.13031
  • Narayanan R, Kelkar A, Abbas Z, et al. Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of intravitreal ranibizumab. BMC Ophthalmol. 2021;21(1):33. doi:10.1186/s12886-020-01757-7
  • Weiss M, Sim D, Herold T, Et A. Compliance and adherence of patients with diabetic macular edema o intravitreal anti-vascular endothelial growth factor therapy in daily practice. Retina. 2018;38(12):2293–2300. doi:10.1097/Iae.0000000000001892
  • Ehlken C, Ziemssen F, Eter N, et al. Systematic review: non-adherence and non-persistence in intravitreal treatment. Graefes Arch Clin Exp Ophthalmol. 2020;258(10):2077–2090. doi:10.1007/s00417-020-04798-2
  • Ehlken C, Helms M, Böhringer D, Agostini HT, Stahl A. Association of treatment adherence with real-life VA outcomes in AMD, DME, and BRVO patients. Clin Ophthalmol. 2017;12:13–20. doi:10.2147/OPTH.S151611
  • Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. Biosimilars in ophthalmology: “Is there a big change on the horizon?”. Clin Ophthalmol. 2018;12:2137–2143. doi:10.2147/OPTH.S180393
  • Grisanti S, Ziemssen F. Bevacizumab: off-label use in ophthalmology. Indian J Ophthalmol. 2007;55(6):417–420. doi:10.4103/0301-4738.36474
  • Available from: https://vrsi.in/wp-content/uploads/2018/02/Avastin_Guidlines_Book.pdf. Accessed January 2, 2022. GUIDELINES FOR INTRAVITREAL INJECTIONS
  • Kim LN, Mehta H, Barthelmes D, Nguyen V, Gillies MC. Meta-analysis of real-world outcomes of intravitreal ranibizumab for the treatment of neovascular age-related macular degeneration. Retina. 2016;36(8):1418–1431. doi:10.1097/IAE.0000000000001142
  • Sharma A, Kumar N, Kuppermann BD, Bandello F, Loewenstein A. Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective. Br J Ophthalmol. 2020;104(1):2–7. doi:10.1136/bjophthalmol-2019-314443
  • Sharma A, Hafeez Faridi M, Kumar N, et al. Immunogenicity and efficacy after switching from original ranibizumab to a ranibizumab biosimilar: real-world data. Eye. 2020;34(6):1008–1009. doi:10.1038/s41433-019-0745-z
  • Bressler NM, Veith M, Hamouz J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year Phase III randomised clinical trial outcomes. Br J Ophthalmol. 2023;107(3):384–391. doi:10.1136/bjophthalmol-2021-319637