Sam Chun Dang Pharm announced on the 20th that its biosimilar 'Bizenpri' of the age-related macular degeneration treatment 'Eylea' (ingredient name aflibercept) has received marketing authorization from the European Medicines Agency (EMA).
Bizenpri is a biosimilar that replicates Eylea from U.S. company Regeneron, and age-related macular degeneration is considered a leading cause of blindness in the elderly. Last year, global sales of Eylea reached approximately $9.523 billion (13.33 trillion won). The U.S. substance patent expired last year, and the European patent is set to expire in November.
In particular, Bizenpri is the world's first biosimilar of Eylea developed in a pre-filled syringe (PFS) form. It received approval from the EMA for two product forms: PFS and vial.
Prior to the EMA, Bizenpri received its product authorization from the Canadian Ministry of Health in June and has been sold locally since July.
A company official stated that Bizenpri will be sold in both Eastern and Western Europe, and explained that the product name has been registered under two different names for this purpose.