Samsung Bioepis has received European Commission (EC) approval for its aflibercept biosimilar, OfubizTM, indicated for ophthalmic diseases. This approval, announced on November 19th, marks Samsung Bioepis' second treatment in the ophthalmology space, following BiubizTM (ranibizumab). The decision comes roughly two months after the European Medicines Agency (EMA)'s drug use advisory committee issued a positive opinion in September.
Addressing Macular Degeneration
OfubizTM is a biosimilar of Eylea, developed by Regeneron, a treatment for ophthalmic conditions including wet age-related macular degeneration. Eylea inhibits neovascularization by targeting vascular endothelial growth factors. Macular degeneration, characterized by aging and inflammation of the macula, a central retinal nerve tissue, can lead to visual impairment and blindness if untreated. Continuous treatment is often necessary to slow disease progression.
Expanding Treatment Options
With this approval, Samsung Bioepis expands its ophthalmic portfolio in Europe. The company now has a total of eight biosimilars commercialized in the European market, with OfubizTM representing their ninth approval. An official from Samsung Bioepis stated, "We are pleased to be able to expand treatment options for patients with ophthalmic diseases through European approval of the second ophthalmic disease treatment, Opubiz. We will continue to strive to provide biopharmaceuticals in various fields."
Market Context
Eylea, the original drug of Ofubiz, generates approximately 12 trillion won in annual global sales. The biosimilar aims to provide a more cost-effective alternative while maintaining similar efficacy and safety profiles.
