Samsung Bioepis said that the European Medicines Agency’s (EMA) Committee for Human Medical Products (CHMP) issued a positive scientific opinion on Byooviz, a biosimilar candidate referencing Lucentis (Ingredient: Ranibizumab)

According to the company, the positive opinion comes only eight months after the EMA started reviewing the company’s marketing authorization application (MAA) in October last year.

“We expect to obtain the MAA approval after a final review by the European Commission (EC), which normally takes about two to three months,” the company said. “If Byooviz obtains final approval from the EC, it will become the first Lucentis biosimilar to receive sales approval in the European market.”

The company was also undergoing an approval process for the treatment in the U.S. since November last year, the company said.

Biogen, Samsung Bioepis’s U.S. and European partner, will market the product after approval, it added.

“The company is happy to have received a positive opinion for the sales approval of Byooviz as the first Lucentis biosimilar in the European market,” Samsung Bioepis CEO Ko Han-seung said. “We will continue to strive to secure a product portfolio in various treatment fields for patients worldwide.”

Lucentis is a treatment for eye diseases such as macular degeneration and diabetic macular edema sold by Roche and Novartis. Global sales for the drug amounted to about 4.6 trillion won ($3.9 billion) in 2019, and the substance patents for the treatment in Europe will expire in January 2022.