Samil Pharmaceutical said it will launch Afilivu (aflibercept), an Eylea biosimilar developed by Samsung Bioepis to treat macular degeneration, in the Korean market on May 1.

The announcement follows the partnership agreement signed between Samil Pharm and Samsung Bioepis in February, granting distribution rights for Afilivu in the Korean market.

Afilivu acts by inhibiting vascular endothelial growth factor (VEGF) to manage macular degeneration and is a biosimilar referencing Eylea, developed by Regeneron.

According to Regeneron and Bayer's earnings report, Eylea's global sales amounted to approximately 17 trillion won ($12.3 billion) last year. According to IQVIA data, Eylea sales in Korea reached 96.8 billion won.

As pharmaceutical firms race to develop biosimilars before Eylea's patent expiration, Samsung Bioepis' Afilivu became the first to receive domestic approval in February. Just two months after approval, Samsung Bioepis secured health insurance coverage for Afilivu.

Afilivu underwent evaluation in a global phase 3 clinical trial under the project name SB15, involving 449 patients with wet age-related macular degeneration across 10 countries, including the U.S. and Korea.

Afilivu exhibited comparable enhancements in best-corrected visual acuity (BCVA) to Eylea up to week 56, demonstrating similar safety, immunogenicity, and pharmacokinetics to the reference drug.

In 2022, Samil Pharm and Samsung Bioepis inked a partnership deal for the domestic distribution rights of Amelivu, a biosimilar of Lucentis (ranibizumab), which has been available for sale since January 2023.

Samil Pharmaceutical Chairman Huh Seung-bum said, "Through our partnership with Samsung Bioepis, we have secured the rights to offer a new macular degeneration treatment, Afilivu, following the launch of Amelivu. This significantly broadens our offerings for both patients and clinicians dealing with macular degeneration."

Lee Jeong-woo, leader of the Retinal Marketing Team at Samil Pharm, emphasized the significance of the biosimilar's launch in alleviating the economic strain on patients and bolstering Korea's health insurance finances. He underscored that the market debut necessitated trust in the product development process and stringent quality control measures.

Park Sang-jin, executive vice president and Head of Commercial Division at Samsung Bioepis, said, the launch of Afilivu will allow the company to provide more treatment opportunities for patients with ophthalmic diseases in Korea utilizing high-quality medicines.

“We will continue to enhance patient benefits through the expansion of biosimilar prescriptions,” he added.