Samchundang Pharmaceutical (SCD) announced on November 24 that it has signed a 20-year exclusive licensing and supply agreement with Fresenius Kabi for its Aflibercept biosimilar, a treatment for various ophthalmic diseases, in the United States and six Latin American countries: Brazil, Mexico, Argentina, Chile, Paraguay, and Colombia.

Fresenius Kabi, known for its portfolio in biopharmaceuticals, medical technologies, and nutritional products for critical and chronic conditions, recently expanded its focus to biosimilar products. Under the agreement, Fresenius Kabi will exclusively market and distribute SCD’s Aflibercept biosimilar in these regions, offering both low-dose (2 mg) and high-dose (8 mg) formulations in vial and pre-filled syringe (PFS) formats. Specific financial details, including upfront payments, milestones, and royalties, remain undisclosed per the contractual agreement.

Aflibercept, sold as Eylea by Regeneron in the U.S. and Bayer in other regions, is widely used to treat ophthalmic conditions such as wet age-related macular degeneration (W-AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Under the agreement, Fresenius Kabi will obtain the necessary regulatory approvals in the respective markets and handle the distribution of the Aflibercept biosimilar, while SCD will oversee development, manufacturing, and supply.

The President of Fresenius Kabi’s Biopharmaceuticals Division commented, "With the addition of the Aflibercept biosimilar to our portfolio, we are expanding into the ophthalmology space, furthering our mission to enhance global patient access to high-quality biosimilars. This represents a significant milestone in our strategic growth objectives."

SCD’s CEO echoed this sentiment, stating, "We are thrilled to finalize this agreement and look forward to seeing the Aflibercept biosimilar approved and commercialized. This partnership combines SCD’s expertise in ophthalmology with Fresenius Kabi’s robust global sales network, creating a solid foundation for improving patient access to affordable treatments for ophthalmic diseases."

The agreement marks an important step for both companies in addressing the global demand for cost-effective biosimilar options in ophthalmology, offering new hope for patients in need of accessible therapies for vision-threatening conditions.