Samsung Bioepis' Byooviz Approved as Interchangeable with Lucentis

Samsung Bioepis annoounced that the FDA has approved the supplemental biologics license application (BLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab). 

The FDA originally approved Byooviz in September 2021 as the first ophthalmology biosimilar in the US for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNV). This latest approval designates Byooviz as interchangeable across all of these approved indications.

For demonstration of interchangeability, the FDA requires that the information presented in the application is sufficient to show that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and its reference product is not greater than the risk of using the reference product without such alternation or switch.”[1] As an interchangeable biosimilar, Byooviz is not expected to result in safety risk or reduction in efficacy, when substituted for Lucentis.[2]

Byooviz has been commercialized by Biogen in the US since June 2022. In November 2019, Samsung Bioepis and Biogen announced that they had entered into an exclusive commercialization agreement for two ophthalmology biosimilar candidates, SB11/Byooviz (ranibizumab) and SB15 (aflibercept) in markets around the world.

References

1. The U.S. Food and Drug Administration. Guidance Document. Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry. Accessed October 2023.

2. BYOOVIZ™ (ranibizumab-nuna) Supplement Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s006ltr.pdf. Accessed October 2023.