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Biosimilars in retinal disease Learning Zone


Read time: 45 mins
Last updated:30th Sep 2022
Published:9th Aug 2022

Advances in ophthalmology podcast series

Expand your knowledge on biosimilars in retinal disease by listening to our Advances in Ophthalmology Podcast Series, featuring expert insights from ophthalmologists and eye specialists.

  • Episode one explores how anti-vascular endothelial growth factor (anti-VEGF) biosimilars may help to address unmet needs in treatment of retinal disease, including earlier access to treatment.
  • Episode two features a discussion on the key clinical evidence behind regulatory approval of the first anti-VEGF biosimilar approved for retinal disease in Europe and the US, outlining its efficacy and safety profile versus its reference biologic
  • Episode three involves an in-depth discussion on the development, testing and approval process for biosimilars across Europe and the US, exploring similarities and differences in aspects such as clinical trial design, reference products and interchangeability

To listen to these podcast episodes, click play below.

Episode 1: Anti-VEGF biosimilars – key to earlier treatment in retinal disease?

In this first episode of the Advances in Ophthalmology Podcast Series, join ophthalmologist Dr Ashish Sharma and guest faculty Dr Nancy Holekamp to explore how anti-vascular endothelial growth factor (anti-VEGF) biosimilars may help to address unmet needs in treatment of retinal disease, including earlier access to treatment. As a potentially more cost-effective solution, and how they may help to improve patient access to care and early treatment.

Episode 2: Anti-VEGF biosimilars in retinal disease – spotlight on clinical evidence

Join ophthalmologist Dr Ashish Sharma and guest faculty Dr Anat Loewenstein, as they explore key evidence behind regulatory approval of the first anti-VEGF biosimilar (ranibizumab-nuna) in the US and Europe. Listen to a brief overview of this biosimilar’s efficacy and safety profile compared to reference ranibizumab in patients with retinal disease and hear expert insights about what these findings mean in practice for retina specialists and ophthalmologists weighing up treatment options for their patients.

Episode 3: Can we trust the development and approval process for biosimilars?

In this episode, Dr Ashish Sharma and guest faculty Professor Francesco Bandello take a deep dive into the biosimilar development, testing and approval processes, exploring similarities and differences across Europe and the US. In this discussion, Dr Sharma and Professor Bandello explore barriers to development and approval of biosimilars, comparing and contrasting key regulatory considerations and requirements, including aspects such as interchangeability and reference products. They also explore how the strong track record of biosimilars in Europe and an understanding of the regulatory process can help healthcare professionals to improve their knowledge and trust in biosimilars, enabling patients to have access to these cost-effective treatment options in practice.

Meet the experts

Sharma Pic.pngDr Ashish Sharma

Dr Sharma is an ophthalmologist at Lotus Eye Hospital in Coimbatore, India. He has published over 90 peer-reviewed articles and book chapters, and is principal investigator on an EMA and FDA phase 3 clinical trials of newer anti-VEGFs. He is also 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

Nancy Pic.pngDr 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 Loewenstein.pngDr 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 Bandello.pngProfessor 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.