Sam Chun Dang Pharm developed the biosimilar (bio-pharmaceutical copy) ‘SCD411’ of the macular degeneration treatment ‘Eylea’ (active ingredient aflibercept), which has received approval in Canada and will begin local sales this month.
The company noted on its website on the 2nd that SCD411 received product approval from the Canadian Ministry of Health on June 26th. Last month, it announced the first overseas export of SCD411, with Canada being the first export country.
SCD411 is a biosimilar that replicates Eylea from Regeneron in the United States, and macular degeneration is considered a major cause of blindness in the elderly. Last year, global sales of Eylea reached approximately $9.523 billion (Hanwha 13.33 trillion won). The U.S. substance patent expired last year, and the European patent is expected to end in November.
In particular, SCD411 is the first Eylea biosimilar developed in the world in a pre-filled syringe (PFS) form. About 90% of the export volume shipped to Canada last month was in PFS form. The company is also developing a high-dose product.
Additional exports are scheduled for the second half of the year, and this export scale exceeds the annual domestic sales volume of Eylea (approximately 170,000 units).
Meanwhile, SCD411 is also advancing into Europe. It recently received a 'positive opinion' for product approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), with a final approval decision expected within 2 to 3 months.