Sam Chun Dang Pharm said on the 12th that France has been added to its contract to supply and sell "SCD411," a biosimilar of Eylea (ingredient name aflibercept) for macular degeneration that it developed in-house, in seven countries including the United States.
SCD411 is a biosimilar copying Eylea by U.S. company Regeneron and is a blockbuster drug (more than 1 trillion won in sales) that treats macular degeneration, a leading cause of blindness in older adults. Last year, Eylea's global sales reached about $9.523 billion (Hanwha 13.33 trillion won).
In particular, SCD411 is the world's first Eylea biosimilar developed in a prefilled syringe (PFS) format. The company is developing low-dose 2 mg and high-dose 8 mg formulations in vial (bottle) and PFS forms. Eylea's U.S. substance patent expired last year, and the European patent is also expected to end this month.
Sam Chun Dang Pharm in December signed an exclusive supply and sales agreement with U.S. partner Fresenius Kabi for the United States and six Latin American countries (Brazil, Mexico, Paraguay, Argentina, Chile, Colombia). Through this correction filing, France, part of the European market, was newly included.
The contract period is 20 years from the product's sale date, and from the 20-year mark it automatically renews every two years. Financial terms such as upfront payment, milestones (running royalties), and profit-sharing ratios are undisclosed at the partner's request.
The company is awaiting European approval. It recently received a "positive opinion" for marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), and a final approval decision is typically made within two to three months.
The company received marketing authorization for SCD411 in Canada in Jun., Europe in Aug., and Korea and Japan in Sep. It is currently negotiating supply contracts with partners in the United States, Russia, and the Middle East. In Jun., the first overseas shipment was made to Canada, the initial export destination.