Reimb for Eylea expanded to 8mg formulation in KOR

Chong Kun Dang leverages its ophthalmology sales network to exclusively sell 2mg and 8mg formulations

Reaffirming original drug position amid three-way biosimilar competition

Chong Kun Dang is expected to gain additional momentum in its clinic-focused sales strategy for Bayer’s macular degeneration treatment Eylea (aflibercept) following the expansion of its reimbursement coverage.

According to Bayer Korea on the 26th, Eylea pre-filled syringe 8 mg (Eylea PFS 8mg) will be reimbursed by national health insurance starting January 1.

Under the Ministry of Health and Welfare notification, reimbursement for Eylea PFS 8 mg applies to ▲ patients with subfoveal choroidal neovascularization due to age-related macular degeneration (AMD), ▲ diabetic macular edema (DME) patients with hemoglobin A1C (HbA1C) ≤10% and a minimum central retinal thickness ≥300µm.

Eylea 8mg is a formulation with a molar dose four times higher than the existing Eylea 2mg, enhancing the duration of efficacy. It is administered monthly for the initial three months, after which the dosing interval can be extended up to 20 weeks based on the patient's condition.

Notably, Eylea PFS 8mg incorporates the pre-filled syringe device ‘OcuClick’ technology. OcuClick is mechanically designed to precisely deliver the recommended dose (0.07ml) into the vitreous cavity, reducing procedure time for healthcare providers and minimizing administration errors.

The reimbursement expansion is expected to positively impact Chong Kun Dang’s penetration into the clinic-level ophthalmology market.

On the 16th, Chong Kun Dang and Bayer Korea signed a domestic distribution and sales agreement for Eylea. Under the agreement, Chong Kun Dang will exclusively handle sales, marketing, and distribution of the entire Eylea 2mg and 8mg product line in clinics.

This partnership reflects the two companies’ aligned strategic interests.

Chong Kun Dang aims to expand its existing lineup of ophthalmic products by leveraging the strong market position of Eylea, while Bayer expects synergies from Chong Kun Dang’s sales and marketing capabilities amid intensifying competition due to the emergence of biosimilars.

Currently, three Eylea biosimilars are approved in Korea: ▲Samsung Bioepis' Afilivu, ▲Celltrion's Eydenzelt, and ▲Sam Chun Dang Pharm’s Vgenfli.

Although Samsung Bioepis' Afilivu was the first to enter the market, its expansion stalled temporarily due to the aftermath of patent disputes. However, it recently won its appeal in the second trial and has now entered full-scale competition preparation.

Celltrion's Eydenzelt is known to have gained a first-mover advantage in the market during Samsung Bioepis's patent dispute. Latecomer Sam Chun Dang Pharm is pursuing a lower drug pricing strategy compared to the other two companies.

While Sam Chun Dang Pharm is adopting a direct sales strategy, Samsung Bioepis and Celltrion are targeting the domestic market through collaborations with Samil Pharmaceutical and Kukje Pharm, respectively.

Chong Kung Dang – Bayer Korea’s Eylea co-promotion agreement signing ceremony

Against this backdrop, Bayer appears to have determined the need to partner with a domestic pharmaceutical company to strengthen its presence beyond tertiary hospitals and into clinics.

Existing partnerships, including Bayer’s collaboration with Chong Kun Dang for Kerendia in chronic kidney disease with type 2 diabetes, likely influenced the decision.

High-dose Eylea’s ability to extend dosing intervals up to 20 weeks may significantly reduce treatment burden for both physicians and patients in clinic settings.

Young-joo Kim, CEO of Chong Kun Dang, stated, “Chong Kun Dang has already accumulated sales and marketing capabilities in ophthalmology based on a diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote Eylea's proven efficacy and safety to further expand its market presence.”

JinA Lee, CEO of Bayer Korea, remarked, “Through our partnership with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong collaboration, we will continue to deliver reliable treatment options to patients with retinal diseases and healthcare professionals in Korea, and consistently contribute to improving patients' quality of life.”