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Biosimilars in retinal disease

Last updated: 22nd Aug 2023
Published: 27th Jul 2022
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Biosimilars in retinal disease Learning Zone
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Fast facts
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Join retinal disease expert Dr Ashish Sharma, an ophthalmologist at Lotus Eye Hospital and Institute in India, to learn some fast facts about biosimilars in retinal disease.
  • Expand your knowledge on the biosimilar development and approval process, and learn why biosimilars have only recently arrived on the market for retinal disease
  • Find out about the clinical effectiveness and safety profile of the first ophthalmology biosimilar to be approved in Europe and the USA – and discover other biosimilars in the pipeline
  • Explore how early and sustained treatment can achieve better outcomes for people with retinal disease, and how biosimilars can improve access to care

 

Learn more about the basics of biosimilars with the “Fast facts” section of the Learning Zone.

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The impact of biosimilars on retinal disease treatment
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What does the availability of biosimilars for the treatment of retinal disease mean for patients and medical professionals in the field? Explore the ‘Biosimilars in retinal disease Learning Zone’ to stay abreast with advances in the use of biosimilars in ophthalmology and how they can improve access to care.

 

Read about biosimilars in retinal disease

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Approving a biosimilar for the treatment of retinal disease improves accessibility, but it also brings challenges. Learn more about these and the opportunities biosimilars present via our Medthority-exclusive podcast with retinal disease expert Dr Ashish Sharma and a range of other key opinion leaders in the field of ophthalmology. Gain unique insights into the role of biosimilars in modern ophthalmology through the fast facts tab.
Ask the experts
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Are there any topics or recent developments on biosimilars you want to know more about? We would love to hear from you.

 

Submit your suggestions and/or feedback

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Meet the experts
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Dr Ashish SharmaDr Ashish Sharma

 

Dr Ashish Sharma is an ophthalmologist at Lotus Eye Hospital in Coimbatore, India. He has published 90 articles in peer-reviewed journals and book chapters, and is principal investigator on an EMA and FDA phase 3 clinical trials of newer anti-VEGFs. Dr Sharma is on the reviewing and editorial board of high impact ophthalmology journals. He has been awarded an International Ophthalmologist Education Award by American Academy of Ophthalmology Board of trustees and Ophthalmic Hero of India by All India Ophthalmic Society. 

 

Disclosures: Dr Sharma has been a consultant and speaker for Intas, Lupin, Novartis and Bayer.

 

Professor Nancy HolekampDr Nancy Holekamp

 

Nancy M. Holekamp, MD is Director of Retina Services at the Pepose Vision Institute in St. Louis, Missouri. She has been a principal investigator in more than 38 national clinical trials dealing with age-related macular degeneration, retinal vascular occlusion, and diabetic retinopathy. She has published 80 peer-reviewed publications and 22 book chapters. She has received the Senior Honor Award and the Secretariat Award from the American Society of Retina Specialists, as well as the Senior Honor Award from the American Academy of Ophthalmology, and the Suzanne Veronneau-Troutman Award in 2018.

 

Disclosures: Dr Holekamp has been on the speaker’s bureau for Allergan, Apellis, Genentech, Regeneron and Spark. She has received consulting fees from Applied Genetics Technologies Corporation, Allergan, Annexon, Apellis, Bayer, Cardinal, Clearside Biosciences, EyePoint Pharmaceuticals, Gemini, Genentech, Gyroscope, Nacuity, NGM, Notal Vision, Novartis, Ocuphire, Outlook Therapeutics, Regeneron, Thea Laboratoires and Stealth Biosciences​. Dr Holekamp has also disclosed contracted research for Genentech, Gemini, Gyroscope and Notal Vision​, and intellectual property/patent with Katalyst Surgical.

 

Dr Anat LoewensteinDr Anat Loewenstein

 

Dr Anat Loewenstein is a Professor of Ophthalmology and Vice Dean of the Faculty of Medicine at Tel Aviv University. Dr Loewenstein was the leader behind the development of novel technology for early detection of macular degeneration, the development of automated technology for detection of retinal disease activity and the development of augmented virtual reality to replace the operating microscope as well as development of home optical coherence tomography (OCT).  Dr Loewenstein has published more than 450 papers in peer reviewed journals and contributed multiple chapters to ophthalmology textbooks. She is Chairman of the Department of Ophthalmology at the Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at the Tel Aviv University, President of the Israeli Ophthalmological Society, and General Secretary of the Euretina board.

 

Disclosures: Dr Loewenstein has been a consultant for AbbVie, Bayer, Beyeonics, Notal Vision, Novartis and Roche.

Professor Francesco BandelloProfessor Francesco Bandello

 

Francesco Bandello is Professor and Chairman at the Department of Ophthalmology University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy. Professor Bandello is President of the Association of Italian University Professors of Ophthalmology CONPROSO), Past President of EURETINA, President of Academia Ophthalmologica Europea and Vice President of EuroLam.  Professor Bandello is Editor-in-Chief of the European Journal of Ophthalmology and former board member of the Club Jules Gonin and Macula Society. He is a member of the Executive Board of ESASO Foundation (European School for Advanced Studies in Ophthalmology), of the Commission of Prevention of Blindness and Low Vision and a S.I.S.O (Società Italiana Scienze Oftalmologiche) member of the Academia Ophthalmologica Internationalis and the Accademia Nazionale di Medicina.  Professor Bandello has co-authored 12 books and serves as a peer reviewer for grant applications for the National Eye Institute. He has authored or co-authored 920 PubMed articles and was a trained Principal Investigator in several clinical trials that followed ICH/GCP, mainly concerning retinal diseases.

 


Disclosures: Professor Bandello has received grants and served as a consultant for AbbVie, Alimera Sciences, Bayer, Boehringer Ingelheim, Fidia Sooft, Hofmann-La Roche, Novartis, NTC Pharma, Oxurion NV and SIFI.

 

 

Ask the experts a question via the “Ask the experts” section of the Learning Zone.

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Key fact
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Biosimilars and treatment accessibility
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Delays in the provision of treatment for retinal disease lead to dramatic impacts on visual acuity.Dr Ashish Sharma has stated that earlier, consistent treatment results in a higher level of visual acuity maintained for a longer period of time. Despite this, undertreatment of retinal disease remains a significant issue.
While there are a number of factors that contribute to the undertreatment of retinal disease, a significant factor is cost. Biologic anti-vascular endothelial growth factor (anti-VEGF) has led to improved patient outcomes and has changed the way we treat retinal disease. However, the high-cost of this revolutionary treatment can be a barrier to access and adequate treatment length, compromising patient outcomes1-3.

Given the financial barriers to accessing anti-VEGF treatment, biosimilars have the potential to make retinal disease treatment more accessible as they are often available at a reduced cost compared with their reference medicine1. Find out more about how biosimilars may make the treatment of retinal disease more accessible via the links below.

Link(s) to relevant sections to read the full content.

 

 

Can biosimilars improve access to care?

Integrating biosimilars into management of retinal disease

Advances in ophthalmology podcast series

References

1. Hariprasad SM, Gale RP, Weng CY, Ebbers HC, Rezk MF, Tadayoni R. An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review. Ophthalmology and Therapy. 2022;11:959-982.

2. Monés J, Singh RP, Bandello F, Souied E, Liu X, Gale R. Undertreatment of Neovascular Age-Related Macular Degeneration after 10 Years of Anti-Vascular Endothelial Growth Factor Therapy in the Real World: The Need for A Change of Mindset. Ophthalmologica. 2020;243(1):1-8.

3. Lim JH, Wickremasinghe SS, Xie J, Chauhan DS, Baird PN, Robman LD, et al. Delay to treatment and visual outcomes in patients treated with anti-vascular endothelial growth factor for age-related macular degeneration. Am J Ophthalmol. 2012;153(4):678-686.

Key fact
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Introducing biosimilars to clinical practice
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Biosimilars offer potential as a more accessible treatment option for retinal disease treatment when compared to reference medicines in the treatment of retinal disease. A range of factors must be considered when transitioning patients from a reference medicine to a biosimilar. must also consider how to discuss the option of biosimilars with patients.

 

With the approval of biosimilars for the treatment of retinal disease in 2021, retinal specialists will naturally be both curious about the potential of this new treatment option whilst being eager to it fits within existing management strategies.
In this Learning Zone, you will find resources on how to navigate the introduction of biosimilars into clinical practice. Dr Ashish Sharma answers a range of questions, including:
  • What are some key considerations when switching from a reference medicine to a biosimilar for retinal disease?
  • Which anti-VEGF biosimilars are approved in Europe and the US, and what others are in development?
  • How does efficacy of anti-VEGF biosimilars compare with that of their reference biologics in retinal disease?

 

 

Can biosimilars improve access to care?

Integrating biosimilars into management of retinal disease

Are biosimilars effective and safe for retinal disease?

Key fact
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Considering the patient during biosimilar switch
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While the use of biosimilars may financially benefit both the patient and the provider, individual patient circumstances must be considered when deciding whether to make the switch.
Both physicians and patients may be concerned about adverse events arising during the switch from a reference medicine to a biosimilar. A large number of studies have shown that efficacy, safety and disease control remain constant between treatment options, the decision to switch should be a shared one between an ophthalmologist and their patient1. Studies have shown that effective communication between healthcare professionals and patients contribute to a successful switch1.
Whereas the ‘nocebo effect’ and related adverse effects may be more likely to arise if a patient has a negative expectation2.
An understanding of biosimilars and their development may be a useful tool in confidently discussing a switch with patients in your practice. Consider listening to our expert-led podcast series covering everything from the unmet needs in the treatment of retinal disease to an in-depth discussion of biosimilar development, testing and approval. For further information on patient considerations, explore the full Learning Zone or engage with the 'Advances in ophthalmology' podcast series covering a varied range of topics aimed to inform your management of retinal disease with biosimilars.

 

 

Link(s) to relevant sections to read the full content.

Advances in ophthalmology podcast series

Integrating biosimilars into management of retinal disease

References

1. Hariprasad SM, Gale RP, Weng CY, Ebbers HC, Rezk MF, Tadayoni R. An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review. Ophthalmology and Therapy. 2022;11:959-982.

2. American Academy of Ophthalmology Academy Board of Trustees. The Use of  Biosimilars in Ophthalmic Practice. January 2022. Available at: https://www.aao.org/clinical-statement/use-of-biosimilars-in-ophthalmic-practice. Accessed 21 April 2022.

Meet the experts

The following experts were involved in the development of the fast fact videos throughout the Learning Zone, or featured in the podcast series.

Dr Ashish SharmaDr Ashish Sharma

Dr Ashish Sharma is an ophthalmologist at Lotus Eye Hospital in Coimbatore, India. He has published 90 articles in peer-reviewed journals and book chapters, and is principal investigator on an EMA and FDA phase 3 clinical trials of newer anti-VEGFs. Dr Sharma is on the reviewing and editorial board of high impact ophthalmology journals. He has been awarded an International Ophthalmologist Education Award by American Academy of Ophthalmology Board of trustees and Ophthalmic Hero of India by All India Ophthalmic Society.

Disclosures: Dr Sharma has been a consultant and speaker for Intas, Lupin, Novartis and Bayer.

Professor Nancy HolekampDr Nancy Holekamp

Nancy M. Holekamp, MD is Director of Retina Services at the Pepose Vision Institute in St. Louis, Missouri. She has been a principal investigator in more than 38 national clinical trials dealing with age-related macular degeneration, retinal vascular occlusion, and diabetic retinopathy. She has published 80 peer-reviewed publications and 22 book chapters. She has received the Senior Honor Award and the Secretariat Award from the American Society of Retina Specialists, as well as the Senior Honor Award from the American Academy of Ophthalmology, and the Suzanne Veronneau-Troutman Award in 2018.

Disclosures: Dr Holekamp has been on the speaker’s bureau for Allergan, Apellis, Genentech, Regeneron and Spark. She has received consulting fees from Applied Genetics Technologies Corporation, Allergan, Annexon, Apellis, Bayer, Cardinal, Clearside Biosciences, EyePoint Pharmaceuticals, Gemini, Genentech, Gyroscope, Nacuity, NGM, Notal Vision, Novartis, Ocuphire, Outlook Therapeutics, Regeneron, Thea Laboratoires and Stealth Biosciences​. Dr Holekamp has also disclosed contracted research for Genentech, Gemini, Gyroscope and Notal Vision​, and intellectual property/patent with Katalyst Surgical.

Dr Anat LoewensteinDr Anat Loewenstein

Dr Anat Loewenstein is a Professor of Ophthalmology and Vice Dean of the Faculty of Medicine at Tel Aviv University. Dr Loewenstein was the leader behind the development of novel technology for early detection of macular degeneration, the development of automated technology for detection of retinal disease activity and the development of augmented virtual reality to replace the operating microscope as well as development of home optical coherence tomography (OCT).

Dr Loewenstein has published more than 450 papers in peer reviewed journals, and contributed multiple chapters to ophthalmology textbooks. She is Chairman of the Department of Ophthalmology at the Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at the Tel Aviv University, President of the Israeli Ophthalmological Society, and General Secretary of the Euretina board.

Disclosures: Dr Loewenstein for AbbVie, Bayer, Beyeonics, Notal Vision, Novartis and Roche.

Professor Francesco BandelloProfessor Francesco Bandello

Francesco Bandello is Professor and Chairman at the Department of Ophthalmology University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy. Professor Bandello is President of the Association of Italian University Professors of Ophthalmology CONPROSO), Past President of EURETINA, President of Academia Ophthalmologica Europea and Vice President of EuroLam.

Professor Bandello is Editor-in-Chief of the European Journal of Ophthalmology and former board member of the Club Jules Gonin and Macula Society. He is a member of the Executive Board of ESASO Foundation (European School for Advanced Studies in Ophthalmology), of the Commission of Prevention of Blindness and Low Vision and a S.I.S.O (Società Italiana Scienze Oftalmologiche) member of the Academia Ophthalmologica Internationalis and the Accademia Nazionale di Medicina.

Professor Bandello has co-authored 12 books and serves as a peer reviewer for grant applications for the National Eye Institute. He has authored or co-authored 920 PubMed articles and was a trained Principal Investigator in several clinical trials that followed ICH/GCP, mainly concerning retinal diseases.

Disclosures: Professor Bandello has received grants and served as a consultant for AbbVie, Alimera Sciences, Bayer, Boehringer Ingelheim, Fidia Sooft, Hofmann-La Roche, Novartis, NTC Pharma, Oxurion NV and SIFI.

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