Sam Chun Dang Pharm partners with Fresenius Kabi for Eylea biosimilar commercialization in US, Latin America

Sam Chun Dang Pharm said it entered a licensing agreement with Germany-based Fresenius Kabi for the global commercialization of its biosimilar SCD411, a biosimilar referencing Regeneron’s Eylea (ingredient: aflibercept), in the U.S. and six nations in Latin America. 

According to a public filing on Monday, Fresenius Kabi will acquire exclusive rights to market SCD411 across the U.S., Brazil, Mexico, Argentina, Chile, Paraguay, and Colombia. While Samchundang will retain responsibility for manufacturing and supply, Fresenius Kabi aims to integrate SCD411 into its portfolio to strengthen its position in the biopharmaceutical market.

The financial terms of the deal, including the upfront payment and milestone fees, remain confidential at the request of Fresenius Kabi. The agreement includes a 20-year contract period from the product's launch date. After 20 years, the contract will automatically renew every two years, according to the filing. 

SCD411 completed global phase 3 clinical trials in 2022, demonstrating comparable efficacy and safety to the original Eylea product. The trials spanned 14 countries, involving 576 patients across 132 hospitals.

The results for the primary efficacy endpoint—the change in best-corrected visual acuity (BCVA)—fell within equivalence margins established by regulatory agencies such as the FDA, EMA, and Japan’s PMDA.

“With the commercialization of the aflibercept biosimilar, we are broadening our product portfolio with a treatment option for ophthalmic diseases,” Fresenius Kabi’s President of Business Unit Biopharma Pak Sang-jin said. “In alignment with our #FutureFresenius strategy, this marks another significant milestone for Fresenius Kabi in fulfilling our strategic objective of enhancing access to biosimilars for patients globally.

Sam Chun Dang Pharm CEO Chun In-seok also said, “We are thrilled to have finalized this agreement and are eager to move forward with the commercialization of our aflibercept biosimilar candidate upon approval.”

The combination of SCD’s specialized expertise in ophthalmology and Fresenius Kabi’s global commercial strength creates a robust foundation to support our shared objective of improving patient access to more affordable treatment options in ophthalmology, Chun added.

As a result of the news, Sam Chun Dang Pharm's share reached its upper limits on Monday. As of market close, the company’s shares stood at 153,500 won ($105.68), up 29.97 percent from the previous trading day.

Obstacles ahead

Despite optimism, the global biosimilar market for aflibercept faces mounting challenges. Patent protections for Eylea have only recently begun to lapse in key markets, with competition already intensifying.

The contract also reveals potential risks for Sam Chun Dang Pharm with the public disclosure highlighting key risks associated with the deal.

Sam Chun Dang Pharm emphasized that revenue recognition remains conditional upon regulatory approvals, and the possibility of non-realization cannot be ruled out. If approvals fail, the contract will be terminated, and 80 percent of the upfront payment refunded to Fresenius Kabi.

Additionally, critical details such as profit-sharing ratios and milestone payments have not been disclosed, leaving questions about the long-term financial benefits of the partnership.