• Commercialization partner MS Pharma wins government tender for Ranibizumab in Saudi Arabia
  • Commercial launch of FYB201/Ravegza® planned for second quarter of 2024
  • Further launches planned throughout 2024 to improve access to ophthalmic treatments in the MENA region

Munich, Germany/Amman, Jordan – Formycon AG (FSE: FYB) and MS Pharma announced today that FYB201, a biosimilar to Lucentis® (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. Following the successful 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 MENA region from the second quarter of 2024. In addition, further 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®.

FYB201/Ravegza® was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. As a biosimilar to Lucentis®, FYB201 has already proven to be an important, cost-effective treatment option for patients with severe retinal diseases in the USA and large parts of Europe.

At the end of 2021, the company entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA) region. This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.

Ravegza® is approved in Saudi Arabia for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes. In Saudi Arabia, millions of individuals grapple with Diabetes Mellitus (DM) and its complications. The prevalence of diabetic retinopathies (DR) is approximately 19.7%[i], resulting from damage to blood vessels in the retina due to prolonged high blood sugar levels. Additionally, Diabetic Macular Oedema (DME) affects 5.7% of the population, leading to fluid accumulation in the macula, vision impairment and even blindness. By inhibiting vascular endothelial growth factor (VEGF), Ravegza® is indicated to treat nAMD and DME effective and cost-efficient.

“The successful approval of FYB201 in Saudi Arabia underlines the quality of our biosimilar and its importance as an affordable treatment option for DME, one of the most common causes of severe visual impairment and blindness in the middle east,” said Nicola Mikulcik, CBO of Formycon. “Our partner MS Pharma winning the important NUPCO tender in Saudi Arabia is an outstanding achievement, as it enables us to serve a significant part of the public healthcare sector in Saudi Arabia.”

Kalle Känd, CEO of MS Pharma, stated, “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.”


[i] AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 2021 Feb;42(2):131-145. doi: 10.15537/smj.2021.2.25623. PMID: 33563731; PMCID: PMC7989293. https://pubmed.ncbi.nlm.nih.gov/33563731/