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The Top 5 Ophthalmology Articles of 2022
Biosimilar news in ophthalmology throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.
Biosimilar news in ophthalmology throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.
5. First Ophthalmology Biosimilar Launches in US
In June, Biogen and Samsung Bioepis announced the US launch of Byooviz, the first ophthalmology biosimilars and the first ranibizumab biosimilar to receive FDA approval and launch on the US market. The drug was developed for the treatment of retinal diseases, including age-related macular degeneration (AMD), diabetic retinopathy, and macular edema. Byooviz was approved in September 2021 and has been approved in the European Union and Canada.
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4. Genentech, Roche Recall Ophthalmology Biobetter Susvimo
Genentech, a member of the Roche group recalled its biobetter of Lucentis (ranibizumab), Susvimo, an ocular implant for ranibizumab injection. The recall was in reference to a possible leakage issue. Biobetters are a class of follow-on biologics that are altered to improve clinical effects, allow for more time in between doses, or enhance drug tolerability. The product was approved in October 2021 and accumulated about $3 million in revenue over the first 9 months of 2022. Susvimo offers a benefit over Lucentis by allowing patients to go up to 6 months between doses.
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3. Biosimilars Check-In: Celltrion Pushes for Yuflyma in Europe; Xbrane Updates on Ranibizumab Filing
Xbrane Biopharma announced that it has received a general advice letter from the FDA regarding its biologics license application (BLA) for a ranibizumab biosimilar candidate. The company was asked to resubmit a new BLA for the biosimilar. The news came after Xbrane was asked to submit additional data following a preliminary review before the FDA could accept the application for review. Xbrane said that it plans to resubmit before the end of 2022.
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2. Teva’s Lucentis Biosimilar Gains UK Approval
The UK Medicines & Healthcare Regulatory Agency approved Teva Pharmaceuticals’ Ongavia, a ranibizumab biosimilar. Ranibizumab is a vascular endothelial growth factor inhibitor to prevent excessive blood vessel formation in the retina. AMD is the leading cause of blindness in developed countries and is expected to impact up to 77 million people across Europe by 2050. The UK approval was based on data from a randomized, double-masked, parallel group, multicenter phase 3 study comparing the safety and efficacy of Ongavia with the reference product in patients with AMD.
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1. Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology
A literature review on the development of ophthalmology biosimilars predicted a strong market and development push for biobetters in the future. Although biobetters can provide enhanced clinical outcomes to reference biologics and biosimilars, biobetter development may require companies to make a much larger investment in development compared with biosimilars. The review went on to describe explain the appeal of products like Susvimo and forecasted the use of bevacizumab biosimilars to treat retinal conditions. It also previewed at least 8 aflibercept biosimilars referencing Eylea that are in development.
