2025. 2. 6. 15:12ㆍKorean Economy
Samchundang Pharmaceutical is set to commercialize its Eylea biosimilar, SCD411, this year. With its overseas partners projecting sales of over 17 trillion KRW ($12.7 billion), the industry is watching closely to see if the product will successfully establish itself in the market. The company aims to leverage price competitiveness to secure market share.
According to Samchundang Pharmaceutical on the 5th, it has signed supply agreements for SCD411 with partners in key global markets, including the U.S., Europe, Canada, and Japan. Among these, sales will begin this year in Europe, Japan, Canada, and South Korea.
In South Korea and Japan, the company aims to receive regulatory approval and commence sales in the first half of this year. Canada is also expected to see market entry during the same period. As for Europe, where Eylea’s original patent is set to expire in November, Samchundang plans to align its approval process accordingly and enter the market thereafter.
Under its SCD411 supply agreements with overseas partners, Samchundang expects to receive contract payments and milestone fees exceeding 240 billion KRW ($180 million). Its partners project total revenue from the biosimilar to exceed 17 trillion KRW ($12.7 billion). The company is currently negotiating additional supply contracts with partners in France, Eastern Europe, Russia, Australia, and the Middle East & Africa, with contract payments and milestone fees estimated to reach the trillion-KRW range.
For the U.S. market, Samchundang has secured a foothold through a licensing deal with Fresenius and its subsidiary, Fresenius Kabi, granting them commercialization rights for the U.S. and Latin America. Sales in the U.S. are expected to begin in the second half of 2025, following regulatory approval.
However, market entry in the U.S. presents challenges. While Eylea’s substance patent expired in May 2023, Regeneron, the original drug developer, continues to defend its formulation patents, some of which extend until 2027, making market penetration difficult. Notably, Samsung Bioepis recently faced a setback when a U.S. court ruled against it in an injunction appeal filed by Regeneron, delaying the launch of its Eylea biosimilar (Opuviz).
Samchundang’s SCD411 U.S. contract includes a high-dose version of the biosimilar. The company has already developed a formulation that circumvents the high-dose patent, positioning itself for early market entry. While the high-dose formulation patent for Eylea extends until 2039, Samchundang aims to enter the market by 2028 using its proprietary workaround.
Expanding R&D in Diabetes and Obesity Treatments
In addition to biosimilars, Samchundang Pharmaceutical is expanding into diabetes and obesity treatments. The company recently initiated a bioequivalence (BE) study for an oral semaglutide product developed using its proprietary S-PASS platform, which converts injectable drugs into oral formulations.
Semaglutide is a GLP-1 receptor agonist widely used for type 2 diabetes treatment and weight management. Samchundang’s oral semaglutide is a generic version of Novo Nordisk’s Rybelsus, but with an improved dosing regimen that reduces the number of required doses, enhancing patient convenience.
Instead of using SNAC, the absorption enhancer found in Rybelsus, Samchundang developed a proprietary SNAC-free formulation based on S-PASS technology, allowing it to bypass multiple formulation patents. The company aims for early commercialization in 2025, once the active ingredient patent expires. Regulatory approval could be filed as early as Q4 2024.
Additionally, Samchundang is developing an oral insulin using its S-PASS technology and is preparing to submit an Investigational New Drug (IND) application soon.
“We aim to commercialize our semaglutide generic by 2026 and introduce an oral insulin product suitable for both type 1 and type 2 diabetes patients, positioning ourselves as a game-changer in the diabetes and obesity treatment market,” said a Samchundang Pharmaceutical representative. “Our goal is to secure global partnerships for sales expansion.”