Ravegza, Lucentis Biosimilar, Granted Marketing Authorization in Saudi Arabia

Formycon AG and MS Pharma announced that their product, Ravegza (FYB201), a biosimilar to Lucentis (ranibizumab), has been granted marketing authorization by the Saudi Food & Drug Authority.

Ravegza is now approved for use in Saudi Arabia for the treatment of wet age-related macular degeneration (AMD) and other severe eye diseases, including diabetes-related retinopathies.

Developed by Bioeq AG, a collaboration between Formycon AG and Polpharma Biologics Group, FYB201/Ravegza represents a significant advancement in the treatment of serious retinal diseases. The product, which mirrors the therapeutic effects of Lucentis, has already received approval in the United States and parts of Europe under various brand names.

The approval of Ravegza in Saudi Arabia follows its successful market launch in Jordan last year and the acquisition of the NUPCO tender in the country. This milestone marks the expansion of FYB201's availability to another country in the Middle East and North Africa (MENA) region from the second quarter of 2024.

Additionally, plans are in motion to introduce the biosimilar in Algeria and other markets within the Gulf Cooperation Council (GCC) throughout 2024. In Saudi Arabia, Ravegza will be marketed by MS Pharma under its trade name, ensuring patients in the region have access to this vital treatment option for severe eye conditions.

Kalle Känd, CEO of MS Pharma, said, “The approval of Ravegza® in Saudi Arabia represents a significant milestone in the company’s ongoing mission to improve patient health and expand our services providing high quality accessible medicines. Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region. We are very proud that we will be making a substantial contribution to public healthcare through the government tender awarded in Saudi Arabia. This approval supports the company’s commitment to the Saudi market and its broader strategic initiatives within the kingdom.”