Lucentis Biosimilar Receives Marketing Authorization from the Saudi Food & Drug Authority

Formycon AG and MS Pharma announced that Ravegza (FYB201), a biosimilar to Lucentis (ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority.

Ravegza is approved in Saudi Arabia for the treatment of patients with wet age-related macular degeneration (AMD) and other serious eye diseases including retinopathies secondary to diabetes. 

FYB201/Ravegza was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group. As a biosimilar to Lucentis, FYB201 is already approved for severe retinal diseases in the US and parts of Europe under different brand names. 

Following the market launch in Jordan last year and with winning the NUPCO tender in Saudi Arabia, FYB201 is expected to be available in another country in the Middle East and North Africa (MENA) region from the second quarter of 2024. In addition, market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024. In Saudi Arabia, MS Pharma will market the biosimilar under the trade name Ravegza.