Alteogen's subsidiary, Alteogen Biologics, said on the 19th that its Middle East and North Africa (MENA) regional partner, Saudi state-owned pharmaceutical and medical device corporations SPIMACO, obtained marketing approval for the macular degeneration treatment Eylea biosimilar (ALT-L9) from the Saudi Food and Drug Authority (SFDA).
SPIMACO is the exclusive partner for ALT-L9 in 16 MENA countries. Last year, it signed an exclusive agreement with Alteogen Biologics for manufacturing, marketing, distribution, and commercialization across 16 countries, and it is currently responsible for regulatory approvals and commercialization. The latest approval is seen as one of the first achievements of securing overseas marketing authorization through the companies' collaboration.
Saudi Arabia's SFDA is regarded as a highly influential regulator in the Middle East. As many MENA countries refer to SFDA approval results when conducting their own reviews, the latest clearance is expected to serve as a springboard for broader approvals across the region.
In the United Arab Emirates (UAE), ALT-L9 is under marketing authorization review, with a decision expected soon. Alteogen Biologics expects other MENA countries to grant approvals in sequence based on the SFDA clearance.
ALT-L9 is a biosimilar of Eylea, used to treat retinal diseases such as macular degeneration. Eylea, developed by U.S. company Regeneron, is a blockbuster drug that generates about 12 trillion won in annual global sales. Through a global phase 3 trial, Alteogen Biologics confirmed equivalence with the reference product and, based on that, received marketing approvals from the European Medicines Agency (EMA) and the Ministery of Food and Drug Safety.
The MENA region is a growth market with more than 500 million residents. Given the region's high prevalence of diabetes, demand is strong for retinal disease treatments such as diabetic retinopathy and macular edema. In addition, due to strong sunlight and improved access to medical care, the ophthalmology market, including treatments for macular degeneration, is also expanding.
Ji Hee-jung, CEO of Alteogen Biologics, said, "SFDA approval in Saudi Arabia is an important milestone for expanding into the Middle East and North Africa market," adding, "Based on this clearance, we expect approval procedures in key MENA countries, including the UAE, to gain further momentum." She added, "We will continue to drive the global expansion of ALT-L9 through collaboration with our local partner."
Meanwhile, SPIMACO is a leading Saudi pharmaceutical company that in 2024 signed an exclusive agreement with Alteogen Biologics covering the manufacturing, marketing, distribution, and commercialization of ALT-L9 in 16 core MENA countries. Under the agreement, SPIMACO is responsible for marketing approvals and commercialization in the region, and it is advancing ALT-L9's market entry based on its local manufacturing capacity in Saudi Arabia and regional network.