This FDA submission follows the licensing agreement under which Fresenius Kabi will exclusively commercialize the biosimilar candidate in the U.S. and several Latin American markets upon regulatory approval.
“This submission is a significant milestone in our partnership with SCD and a testament to our shared commitment to improving patient access to affordable treatment options in ophthalmology,” said Dr. Sang-Jin Pak, President Biopharma, Fresenius Kabi. “It aligns with our #FutureFresenius strategy and reinforces our dedication to expanding our biosimilar portfolio globally."
About Fresenius Kabi
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 130 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
For more information, please visit www.fresenius-kabi.com.
About SamChunDang Pharm
SCD is based in South Korea and specializes in developing generics and biosimilars for global markets. For more information, visit the SamChunDang Pharm website.
* Eylea® is a registered trademark of Regeneron.