Samsung Bioepis said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion on Opuviz (SB15), a biosimilar candidate referencing Eylea (ingredient: aflibercept).

According to the company, the positive opinion was issued after a thorough review of its marketing authorization application (MAA) submitted earlier this year.

A positive opinion from the CHMP is a critical milestone in the approval process by the European Commission (EC). Typically, a formal decision on marketing authorization is made within two to three months after a positive opinion is issued.

Opuviz is a biosimilar of the original drug Eylea, developed by U.S.-based Regeneron, and is used for the treatment of ophthalmic diseases such as wet age-related macular degeneration (AMD).

Eylea works by inhibiting the formation of new blood vessels through binding to vascular endothelial growth factor (VEGF). The global market for Eylea is substantial, with annual sales reaching approximately 12 trillion won ($8.9 billion) in 2023.

Biogen, Samsung Bioepis’ partner for the U.S. and European markets, will handle marketing and distribution in Europe once the final approval is granted.

“We are delighted to have received a positive opinion for Opuviz, our second ophthalmology biosimilar, following Byooviz,” Samsung Bioepis Regulatory Affairs Vice President Jung Byung-in said. “We will continue to expand our product portfolio to offer more treatment options for patients globally.”