Samchundang Pharm Reaches Global Settlement in Eylea Biosimilar Patent Dispute, Clearing Path for SCD411 Commercialization
核心洞察
Samchundang Pharm (搜索) has reached a settlement with Regeneron Pharmaceuticals and Bayer Consumer Care (搜索) to conclude the global patent dispute over SCD411, its Eylea (aflibercept 2 mg) biosimilar.
The agreement dismisses all pending patent litigation in Europe, Japan, and South Korea, following earlier settlements covering the United States and Canada.
The resolution substantially clears legal uncertainties that had been blocking commercialization, shifting the key variable for SCD411's value from regulatory approval to actual sales performance.
Samchundang Pharm (搜索) has effectively resolved the global patent dispute surrounding its biosimilar of the macular degeneration treatment Eylea, substantially clearing the legal uncertainties that had been blocking commercialization in key markets. Following earlier settlements covering the United States and Canada, the company has now reached agreement with the originator developers in Europe, Japan, and South Korea.
Samchundang Pharm (搜索) announced on the 18th that it has entered into a settlement agreement with Regeneron Pharmaceuticals and Bayer Consumer Care (搜索) to conclude the global patent dispute concerning SCD411 (active ingredient: aflibercept 2 mg), its Eylea biosimilar. Under the terms of the settlement, all patent litigation pending in the covered territories — including Europe, Japan, and South Korea — will be dismissed. Patent opposition proceedings before national patent offices and the European Patent Office (EPO) will also be concluded.
Comprehensive Resolution Across Major Markets
Samchundang Pharm (搜索) had already reached separate settlements with Regeneron in the United States and Canada. In the US specifically, the company announced in February that it had resolved the patent dispute through a settlement with its local partner. However, uncertainty lingered as Regeneron subsequently pursued discovery proceedings against Samchundang Pharm's US subsidiary.
In April, Regeneron filed a motion in the US District Court for the District of Delaware seeking to compel Samchundang Pharm (搜索)'s US subsidiary to produce its Biologics License Application (BLA) and manufacturing process records related to Eylea. Samchundang Pharm countered by seeking to quash the discovery order and dismiss the subpoena. In July, the court ordered the matter to be separated into a standalone proceeding for review.
With this latest settlement, the company has now comprehensively resolved patent-related disputes surrounding SCD411 commercialization across major markets, securing a foundation to pursue global sales.
Accelerating Global Market Penetration with Vizempre
SCD411 is a biosimilar of Eylea 2 mg. Eylea, whose active ingredient is aflibercept, is an ophthalmic treatment used for wet age-related macular degeneration (搜索) and diabetic macular edema (搜索). As patents have begun expiring in major countries, competition among biosimilar developers has intensified.
Samchundang Pharm (搜索) is supplying the biosimilar under the brand name Vizempre (搜索) in Canada, Europe, and the South Korean domestic market. The company exports ophthalmic solutions to Europe and the United States through EU GMP-certified production facilities, and has recently been focusing on developing drug delivery platforms to improve the convenience of existing treatments.
In particular, the company is developing technologies to convert injectable drugs into oral formulations, long-acting injectables, and subcutaneous formulations of intravenous drugs. Leveraging these platforms, it is also developing oral insulin and oral semaglutide.
The Significance of Resolving Patent Risk
For biosimilars, patent issues — not just regulatory approval — are considered a critical variable that can determine the actual timing of market entry. Even with marketing authorization, unresolved patent issues inevitably create uncertainty around launch timing and business valuation.
A pharmaceutical and biotech industry source commented: "For biosimilars, even after receiving approval, unresolved patent issues inevitably create uncertainty around launch timing and business valuation. Reaching settlements with originator companies in major markets enhances the predictability of future commercialization timelines."
With legal uncertainties in major markets now substantially cleared, the key variable determining SCD411's future business value is expected to shift from regulatory approval and development to actual sales performance and market penetration.
A Samchundang Pharm (搜索) representative stated: "With this global patent settlement as a catalyst, we plan to accelerate the expansion of our overseas business, including ophthalmic biosimilars."