On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).
The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes. Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.
ALT-L9 is the first biosimilar developed by Alteogen. Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.
ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025. In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.
There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region. This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.