Samsung Bioepis has begun its direct commercialization of Byooviz, which is a biosimilar to Genentech’s Lucentis – ranibizumab in Europe.
The company has gone ahead and bought the commercial rights for Byooviz from Biogen, and the product is now going to be available as a brand from Samsung Bioepis throughout many European countries as part of the ongoing expansion plans that it has.
It was in August 2021 that Byooviz went on to receive an approval from the European Commission – EC as a single-use vial when it comes to intravitreal administration – 0.5mg/0.05ml.
It is indicated for treatment in terms of visual impairment because of diabetic macular oedema, neovascular – wet age-related macular degeneration, visual impairment due to choroidal neovascularization, and proliferative diabetic retinopathy, as well as visual impairment because of macular oedema secondary to retinal vein occlusion – branch or central.
The Committee for Medicinal Products for Human Use – CHMP of the European Medicines Agency – EMA issued quite a positive opinion for the Byooviz pre-filled syringe – PFS in November 2025. The syringe is expected to enter the European market sometime in the second quarter of 2026.
Antonio Rito, the vice-president of Samsung Bioepis said that direct commercialization of Byooviz indeed a major milestone for Samsung Bioepis since the company continues to make its presence across Europe very robust through expanding its portfolio when it comes to directly commercialized products.
He added that making utmost use of the last three years of experience with Epysqli – eculizumab and the newly launched Obodence – denosumab along with Xbryk – denosumab in Europe, they are going to continue with their journey to become a completely integrated biopharmaceutical company having end-to-end capabilities right from development to commercialization.
They are going to work closely along with payers as well as healthcare professionals in order to make sure of a seamless access when it comes to their biosimilar medicines for patients who are in need.
In September 2023, Sandoz went on to collaborate with Samsung Bioepis in order to develop and also market a Stelara – ustekinumab, a biosimilar in the US, Canada, and Europe.
