Samsung Bioepis Receives European Approval for Macular Degeneration Treatment 'Opuviz'

Samsung Bioepis announced on the 19th that its biosimilar of the ophthalmic disease treatment drug Eylea, 'Opufyz,' has received marketing authorization from the European Commission (EC).

Exterior view of the Samsung Bioepis building located in Songdo, Incheon. Provided by Samsung Bioepis

Eylea, developed by Regeneron in the United States, is a treatment for ophthalmic diseases such as wet age-related macular degeneration. It binds to vascular endothelial growth factor to inhibit the formation of new blood vessels. Its annual global sales reach approximately 12 trillion KRW.

Macular degeneration is a disease that causes vision impairment due to aging, inflammation, and other factors affecting the macula, the central neural tissue of the retina. In severe cases, it can lead to blindness. Continuous treatment is necessary to slow the progression of macular degeneration.

With this approval, Samsung Bioepis has expanded its portfolio of related treatments by adding Opufyz to its existing biosimilar of the ophthalmic disease treatment drug Lucentis, 'Byooviz.'

Furthermore, having commercialized a total of eight biosimilar products in the European market to date, Samsung Bioepis has now obtained its ninth approval in Europe with the authorization of Opufyz.

Previously, Opufyz received marketing authorization in the United States in May and is being sold domestically under the product name 'Afilibu' through its partner, Samil Pharmaceutical.