Samsung Bioepis Eylea Biosimilar Reconfirms Efficacy in Detailed Phase 3 Clinical Trial Results

Samsung Bioepis announced on the 26th that it presented the follow-up research results of the Phase 3 clinical trial of SB15, developed as a biosimilar of Eylea, at the Asia-Pacific Academy of Ophthalmology (APAO) annual conference held in Bali, Indonesia, from the 22nd to the 25th (local time).

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

Eylea is an ophthalmic drug developed by Regeneron in the United States for treating diseases such as wet age-related macular degeneration (AMD). Macular degeneration is considered a representative cause of blindness. Blood and other fluids leaking from abnormally grown capillaries in the macula, the central part of the retina, adhere to the retina and obscure vision. Therefore, it is necessary to regularly administer Eylea or similar mechanism antibody treatments like Lucentis to inhibit disease progression by preventing new blood vessel formation.

In particular, aging is a major cause, and with global aging, the incidence is increasing significantly worldwide. Global market research firm GlobalData forecasts that the market for macular degeneration treatments in the seven major G7 countries, including the United States, France, and Germany, will grow from $7.4 billion in 2021 to $27.5 billion (approximately 37 trillion KRW) by 2031. Eylea is also considered a global blockbuster, having recorded sales of $9.3806 billion (approximately 12.5 trillion KRW) last year.

In South Korea, it was approved under the product name Apilibu by the Ministry of Food and Drug Safety on the 23rd, and approval procedures are underway in major regions such as the United States and Europe. Domestic sales are handled by Samil Pharmaceutical, which recently signed the licensing agreement. Samil Pharmaceutical also markets Amelibu, a Lucentis biosimilar developed by Samsung Bioepis.

The abstract released at this conference included subgroup analysis results of 103 Asian patients with wet age-related macular degeneration (nAMD) who participated in the SB15 Phase 3 clinical trial (82 from Korea, 21 from Japan). This was a follow-up analysis extracting data from the Asian region among 449 patients across 10 countries in the global Phase 3 clinical trial conducted from June 2020 to March 2022. The study included 52 patients who received SB15 up to week 56, 24 patients who received the original drug, and 26 patients who switched from the original drug to SB15 starting at week 32.

The results showed that the key indicator, best-corrected visual acuity (BCVA), improved similarly across all groups: 8.3 letters in the SB15 group, 7.0 letters in the original drug group, and 6.8 letters in the switch group. The types and frequencies of adverse events were similar, with no new safety signals or anti-drug antibodies, which are indicators of immunogenicity, detected.

Kim Hyejin, Medical Team Leader (Executive Director) at Samsung Bioepis, explained, “The subgroup analysis within the Asian region confirmed the equivalence to the original drug, consistent with the previous global clinical trials, reaffirming the efficacy of SB15.”