FYB201/Ranibizumab Gains Approval and Scheduled for Launch in the MENA Region

Formycon AG and MS Pharma announced the receipt of marketing authorization from the Saudi Food & Drug Authority for FYB201, a biosimilar to Lucentis® (Ranibizumab), marking a significant step towards its commercial launch in the MENA region, beginning with Saudi Arabia in Q2 2024. This follows FYB201's successful market introduction in Jordan previously and signifies its continued expansion with plans for additional launches, including in Algeria and other Gulf Cooperation Council (GCC) markets within the year.

The partnership between Formycon AG and MS Pharma, initiated at the end of 2021, focuses on enhancing access to ophthalmic treatments across the Middle East and North Africa. Ravegza®, the trade name under which FYB201 will be marketed in Saudi Arabia, is positioned as a cost-effective option for treating severe retinal diseases, including age-related neovascular (wet) macular degeneration (nAMD) and diabetes-induced retinopathies. Such conditions are prevalent and significant health concerns in the region, with diabetic retinopathies affecting approximately 19.7% and Diabetic Macular Oedema affecting about 5.7% of the population in Saudi Arabia.

The approval of FYB201/Ravegza® underlines not only the potential health impact it promises but also the commercial achievements of Formycon AG and MS Pharma in securing a government tender in Saudi Arabia. This progress reflects a broader commitment to providing accessible, high-quality medicinal treatments in the MENA region, especially for chronic and severe visual impairments.