Biosimilar

FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with age-related neovascular macular degeneration (nAMD) and other serious retinal diseases.

The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15.

Afqlir (aflibercept) is a 2 mg vial kit and pre-filled syringe for intravitreal injection.

The CHMP will recommend SB15, biosimilar to aflibercept (Eylea), for marketing authorisation by the European Commission

According to the company, the FDA approval strengthens its biosimilar position in the US market.

LUBT010 is a ranibizumab biosimilar to Lucentis that achieved its primary endpoint in this study.

The company expects approval from the EMA by 2025.

The biosimilar was approved for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

The agency approved Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis, Biogen) as biosimilars to Eylea (Regeneron Pharmaceuticals).