The International Biosimilar Retina Study Group (Inter-BIOS Study Group) has recently published the results of the largest survey of biosimilar awareness amongst retina specialists practicing in the US and Europe [1]. The Survey was targeted at 200 retina specialists (100 from the US and 100 from Europe) and 112 retina specialists (55 from the US and 57 from Europe) responded. These results were presented at the 22nd Euretina Congress held in Hamburg, Germany [2], and also at the American Academy of Ophthalmology 2022 Annual Meeting held in Chicago, USA [3]. Following were the major findings of this survey:
1. Familiarity of retina physicians with biosimilar anti-VEGF
The survey revealed that majority of the physicians were familiar with anti-vascular endothelial growth factor (VEGF) biosimilars. However, only a few had complete understanding. Most of the responding physicians sought educational information about safety, efficacy and performance for a better understanding of anti-VEGF biosimilars. majority of the respondents agreed that the major advantage of biosimilars over originators was the lower pricing. majority of the physicians correctly responded that biosimilars and generic medications were not the same. However, when asked about the recently US Food and Drug Administration (FDA)- and European Medicines Agency-approved ranibizumab biosimilar, only 45.5% of physicians were aware.
2. Incorporation of biosimilars into clinical practice
Lower cost was not a significant factor for physicians to switch to biosimilars. However, majority of the physicians wanted to have more information and real-world data about biosimilar molecules before making this switch. A very small number of clinicians (15.17%) responded that they would initiate treatment with a ranibizumab biosimilar.
3. Concerns regarding biosimilar anti-VEGF
Majority of the retina specialists were concerned about the quality, safety and efficacy of these molecules.
4. Awareness about on-label bevacizumab
Most of the physicians were under the mistaken impression that ONS-5010 (Lytenava from Outlook Therapeutics) is a biosimilar of bevacizumab which is wrong because to refer to a drug as a biosimilar, it is mandatory to have an on-label originator drug for the same indication. This has never been the case with bevacizumab for retinal diseases. Hence, on-label bevacizumab is considered an innovator molecule, and if it gets approval, it might be granted 12 years of market exclusivity if it receives FDA approval [4].
5. Awareness comparison of US and European retina specialists
Compared to physicians from Europe, more retina specialists from the US expressed concern about the safety and efficacy of the treatment. Most interestingly, when asked whether lower-cost ranibizumab biosimilars would prompt a shift from off-label bevacizumab to FDA-approved low-cost ranibizumab biosimilars, physicians from Europe were much more in favour compared to physicians from the US. Similarly, when asked if they would use on-label bevacizumab (ONS-5010) instead of off-label bevacizumab with FDA approval, physicians from Europe were more in favour compared to physicians from the US.
To summarize, The Bio-USER survey revealed that the majority of retinal physicians need additional information regarding safety, efficacy and immunogenicity when making clinical decisions regarding their use. Real-world data of biosimilar might be of help in improving confidence on biosimilars in retina. Retinal physicians from the US are more comfortable in continuing to use off-label bevacizumab compared to physicians from Europe.
Conflict of interest
Dr Ashish Sharma reported that he is a consultant for Intas Pharmaceuticals, Lupin Ltd, Novartis India, Bayer India. For full details of the authors’ conflict of interest, see the research paper [1].
Abstracted by Dr Ashish Sharma, Consultant Retina and Head Research, Lotus Eye Hospital and Institute, Coimbatore, TN, India.
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References
1. Sharma A, Holz FG, Regillo CD, et al. Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey). Expert Opin Biol Ther. 2023 Feb 1. doi:10.1080/14712598.2023.2176218
2. Sharma A, Holz FG, Regillo CD, et al. Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey). Available from: https://euretina.org/resource/abstract_2022_biosimilars-for-retinal-diseases-united-states-europe-awareness-survey-bio-user-survey/
3. Wills Eye Hospital. AAO 2022 Presentations. Available from: https://www.willseye.org/wills-at-aao-papers-posters-2022/
4. Outlook therapeutics presents NORSE TWO phase 3 pivotal safety and efficacy data for ONS-5010/LYTENAVA™ (bevacizumab-vikg) at the retina subspecialty day, American Academy of Ophthalmology (AAO) 2021 Annual Conference. Available from: https://www.globenewswire.com/news-release/2021/11/13/2333715/0/en/Outlook-Therapeutics-Presents-NORSE-TWO-Phase-3-Pivotal-Safety-and-Efficacy-Data-for-ONS-5010-LYTENAVA-bevacizumab-vikg-at-the-Retina-Subspecialty-Day-American-Academy-of-Ophthalmo.html
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