ADVANCEMENTS IN OPHTHALMIC BIOSIMILARS: A PARADIGM SHIFT IN RETINAL DISEASE MANAGEMENT

Authors

  • Hussain Ahmad Khaqan Postgraduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Raheela Naz Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Hafiz Ateeq ur Rehman Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan
  • Laraib Hassan Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Nabeel Akram Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Hafiz Mubashir Farooqui Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Ahmad Fauzan Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Asad Mahmood Khan Post Graduate Medical Institute, Ameer ud Din Medical College, Lahore General Hospital, Lahore, Pakistan.
  • Muhammad Iqbal Asif Karachi Medical & Dental College, Karachi, Pakistan
  • Neeta Maheshwary Helix Pharma, Karachi, Pakistan
  • Arjumand Ahmed Helix Pharma, Karachi, Pakistan

DOI:

https://doi.org/10.69656/pjp.v20i2.1613

Keywords:

Diabetic Macular Edema (DME), Anti-VEGF Agents, Biosimilar, Efficacy, Visual Acuity

Abstract

Diabetes macular oedema (DME) stands as the most prevalent cause of vision impairment. This systematic review aimed to assess clinical studies on the efficacy of top anti-vascular endothelial growth factor (anti-VEGF) agents and their biosimilars in treating diabetic macular œdema. This meta-analysis delves into the transformative impact of biosimilars on retinal disease management in ophthalmology, focusing on the global approval and increasing integration of bevacizumab and adalimumab biosimilars. The bevacizumab biosimilars section explores their approval and cost-effectiveness, particularly in the nuanced application of bevacizumab for retinal diseases. This study highlights the potential utility of biosimilars in treating non-infectious uveitis and discusses economic implications and feasibility in retinal disease management. The profound transformation in retinal disease management, specifically in DME, is underscored, emphasizing the shift from traditional approaches to anti-VEGF therapies, and positive outcomes in visual and anatomical aspects are cited. Addressing a critical need, the abstract emphasizes ongoing research into the long-term efficacy and safety of biosimilars. The importance of guidelines and thorough investigations for sustained positive patient outcomes is highlighted. The continuous quest for innovative therapies to enhance vision outcomes for DME patients is acknowledged. Underscoring the significance of stringent quality control and pharmacovigilance, it emphasizes the need for robust monitoring and immunogenicity testing assays before market approval. The meta-analysis summarizes the monumental shift in retinal disease management due to biosimilar advancements, highlighting their potential for economic solutions and a broader array of treatment options.

Pak J Physiol 2024;20(2):70-4

Downloads

Download data is not yet available.

References

Jain A, Sarraf D, Fong D. Preventing diabetic retinopathy through control of systemic factors. Curr Opin Ophthalmol 2003;14(6):389–394.

Banker A. A new biosimilar ranibizumab for retinal diseases. Paper presented at: American Society of Retina Specialists Annual Meeting; August 9–14, San Francisco, CA; 2016.

Blank T, Vogt-Eisele A, Kaszkin-Bettag M, Netzer T, Hildebrandt W. Safety and toxicity of biosimilars –EU versus US regulation. GaBI J 2013;2(3):144–50.

Centers for Disease Control and Prevention. National Diabetes Fact Sheet: National estimates and general information on diabetes and pre diabetes in the United States, 2011. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA, USA. 2011.

ClinicalTrials.gov [Internet]. Bethesda, MA: US National Library of Medicine. A Study to compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in subjects with neovascular age-related macular degeneration (AMD). URL: https://clinicaltrials.gov/ct2/ show/NCT03150589?cond=SB11&rank=1 [Accessed 16 May 2018].

Coherus BioSciences [Internet]. Redwood City, CA: Coherus BioSciences. URL: https://www.coherus.com/our-products/ [Accessed May 16, 2018].

DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ 2016;47:20–33.

Entine J. FDA balances costs, patient safety in the biologics and personalized medicine revolution. Forbes 2012.

Formycon [Internet]. Martinsried, Germany: Formycon and BIOEQ achieve important milestone: biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study. URL: http://www.formycon.com/en/ press-release/formycon-and-bioeq-achieve-important-milestone-biosimilar-ranibizumab-candidate-fyb201-shows-efficacy-comparable-to-the-reference-product-in-phase-iii-study/ [Accessed May 16, 2018].

FDA [Internet]. Silver Spring MD: US Food and Drug Administration. Available from: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm [Accessed Sep 23, 2018].

GaBI Online [Internet]. Mol, Belgium: Generics and Biosimilars Initiative. URL: http://www.gabionline.net/Biosimilars/General/ Mylan-Momenta-announce-development-strategy-for-aflibercept-biosimilar [Accessed May 16, 2018].

GM Insights [Internet]. Ocean View, DE: Global Market Insights. Available from: https://www.gminsights.com/industry-analysis/ diabetic-retinopathy-market-report [Accessed May 16, 2018].

Indian Express [Internet]. New Delhi: The Indian Express. URL: http://indianexpress.com/article/business/companies/undertaking-detailed-analysis-patients-report-eye-inflammation-intas-recalls-its-drug-batch-4596914/ [Accessed May 16, 2018].

Regeneron [Internet]. Eastview, MN: Regeneron. Available from: http://investor.regeneron.com/releasedetail.cfm?releaseid=1047691 [Accessed May 16, 2018].

Ding J, Wong TY. Current epidemiology of diabetic retinopathy and diabetic macular edema. Curr Diab Rep 2012;12(4):346–54.

Kempen JH, O’Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, et al. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol 2004;122(4):552–63.

Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 2012;35(3):556–64.

Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: US, 2005–2050. Diabetes Care 2006;29(9):2114–6.

Stefanini FR, Badaró E, Falabella P, Koss M, Farah ME, Maia M. Anti-VEGF for the management of diabetic macular edema. J Immunol Res. 2014;2014:632307. doi: 10.1155/2014/632307.

Blumenkranz MS. Optimal current and future treatments for diabetic macular oedema. Eye (Lond) 2010;24(3):428–34.

Photocoagulation for Diabetic Macular Edema, Early treatment diabetic retinopathy study report number 1. Early Treatment Diabetic Retinopathy Study Research Group. Arch Ophthalmol 1985;103(12):1796–806.

PR Newswire [Internet]. New York, NY: PR Newswire. Available from: https://www.psmarketresearch.com/market-analysis/age-related-macular-degeneration-market. [Accessed May 16, 2018].

Sharma S, Khan MA, Chaturvedi A, RE-ENACT Study Investigators Group. Real life clinical effectiveness of Razumab® (World’s first biosimilar ranibizumab) in retinal vein occlusion: A subgroup analysis of pooled retrospective RE-ENACT study. Ophthalmologica 2019;241(1):24–31.

Li YF, Ren Q, Sun CH, Li L, Lian HD, Sun RX, et al. Efficacy and mechanism of anti-vascular endothelial growth factor drugs for diabetic macular edema patients. World J Diabetes 2022;13(7):532–42. doi: 10.4239/wjd.v13.i7.532.

Abouelkheir H, Elshafey M, Othman MM, Saber MM, el-Ansarey H, Kamel R. Safety of intravitreal anti VEGF injections in diabetic macular edema. Egyptian J Ophthalmol (Mansoura Ophthalmic Center) 2023;3(2):82–92. doi: 10.21608/ejomos.2022.148575.1061.

Cheema AA, Cheema HR. Diabetic macular edema management: A review of anti-vascular endothelial growth factor (VEGF) therapies. Cureus 2024;16(1):e52676. doi: 10.7759/cureus.52676.

Uludag G, Hassan M, Matsumiya W, Pham BH, Chea S, Than NTT, et al. Efficacy and safety of intravitreal anti-VEGF therapy in diabetic retinopathy: what we have learned and what should we learn further? Expert Opin Biol Ther 2022;22(10):1275–91. doi: 10.1080/14712598.2022.2100694

Downloads

Published

30-06-2024

How to Cite

1.
Khaqan HA, Naz R, ur Rehman HA, Hassan L, Akram N, Farooqui HM, et al. ADVANCEMENTS IN OPHTHALMIC BIOSIMILARS: A PARADIGM SHIFT IN RETINAL DISEASE MANAGEMENT. Pak J Phsyiol [Internet]. 2024 Jun. 30 [cited 2024 Nov. 21];20(2):70-4. Available from: https://pjp.pps.org.pk/index.php/PJP/article/view/1613