Samsung Bioepis gets EC's approval for Opuviz

South Korea's Samsung Bioepis Co., Samsung Biologics Co.'s fully owned biosimilar subsidiary, and the US-based Biogen said on Tuesday the European Commission (EC) approved Opuviz (Aflibercept), its biosimilar to Beyer’s Eylea for the treatment of various eye diseases.

Opuviz is the second ophthalmology biosimilar approved in Europe and the fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen.

In November 2019, Samsung Bioepis and Biogen announced that they had entered a commercialization agreement for two ophthalmology biosimilar candidates, Byooviz and Opuviz in the US, Canada, and Europe. 

Eylea, which generates global annual sales of about 12 trillion won ($9 billion), is used to treat wet age-related macular degeneration (AMD) and other retinal conditions by binding to vascular endothelial growth factor (VEGF) and inhibiting abnormal blood vessel growth.

AMD, which damages the central neural tissue of the retina, can cause severe vision impairment and blindness without ongoing treatment.

Opuviz was approved in the US in May and is marketed in South Korea as Afilivu through its partner Samil Pharmaceutical.

Write to Dae-Kyu Ahn at powerzanic@hankyung.com