Sam Il Pharmaceutical's Eylea Biosimilar "Afilivu" Makes Smooth Market Return After Sales Resumption

Sam Il Pharmaceutical's macular degeneration treatment "Afilivu," which resumed sales in December, is once again gaining prominence in the market.

Sales of "Afilivu" were halted early last year due to an injunction granted in a patent dispute with Regeneron. However, in December, a court decision lifted the sales ban, normalizing domestic distribution. As a result of this ruling, "Afilivu" is now recognized as having secured both legal market entry and supply stability.

Since resuming sales in December, Sam Il Pharmaceutical has rapidly recovered sales, achieving cumulative revenue of 1.6 billion won to date.

"Afilivu" (active ingredient: aflibercept) is a biosimilar of Samsung Bioepis's macular degeneration treatment "Eylea," and Sam Il Pharmaceutical holds the exclusive domestic distribution and sales rights.

The main ingredient, aflibercept, inhibits vascular endothelial growth factor (VEGF), thereby preventing abnormal blood vessel growth in the eye. By blocking VEGF, it slows or reduces retinal damage and helps preserve vision, making it an effective treatment for macular degeneration. Macular degeneration is a disease that impairs vision due to aging or inflammation of the macula, the central nerve tissue of the retina, and can lead to blindness in severe cases. The ongoing need for treatment also imposes a significant financial burden on patients.

According to IQVIA data, the domestic market size for Eylea is approximately 87 billion won, making competition in the Korean market intense. Recently, prefilled syringe types (products with the drug preloaded in the syringe) have been launched, further intensifying competition by improving dosing convenience. Samsung Bioepis is also developing a prefilled syringe type, which is expected to be introduced to the domestic market through Sam Il Pharmaceutical as early as the first quarter of this year.

A company representative stated, "Since resuming sales of Afilivu, revenue has recovered more quickly than expected," and added, "With the launch of the prefilled syringe type, prescription expansion will accelerate, further strengthening our position in the Eylea biosimilar market." The representative also said, "We expect meaningful company-wide growth this year, driven by the resumption of Afilivu sales and strong performance in the CNS (central nervous system) business."