Samsung Bioepis has secured marketing authorization from the European Commission (EC) for Opuviz (SB15), a biosimilar of Regeneron's Eylea, a treatment for ophthalmic conditions including wet age-related macular degeneration (AMD). The approval, announced on November 19, expands treatment options for patients suffering from vision impairment due to macular degeneration, a condition affecting the central nerve tissue of the retina and potentially leading to blindness. Eylea, the original drug, has annual global sales of approximately ₩12 trillion.
Opuviz is Samsung Bioepis' second ophthalmic treatment, following the Lucentis biosimilar Byooviz. The EC's decision comes after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in September, granting final marketing authorization within approximately two months.
"We are pleased to expand treatment options for patients with ophthalmic diseases through the European approval of our second ophthalmic disease treatment, Opuviz," said Jung Byung-in, head of RA at Samsung Bioepis. "We will continue to strive to provide a variety of biopharmaceuticals in the future."
With the European approval of Opuviz, Samsung Bioepis now has nine biosimilars approved in Europe. Opuviz received marketing authorization in the United States in May and is sold as Apilivu (SB15 domestic product name) in Korea through its partner, Samil Pharmaceutical, since February.
