Alteogen(129,500 -3.79%)Announced on the 5th that it has completed phase 1 clinical trials of the Ilia biosimilar (generic biopharmaceutical drug) for the first time in Korea. It is explained that it has secured global competitiveness such as registration of formulation patents in the US and Europe, and international (PCT) applications for production patents.
The trial was conducted on 28 patients with neovascular (wet) age-related macular degeneration at four domestic hospitals, including Seoul Asan Hospital, Bundang Seoul National University Hospital, Samsung Seoul Hospital, Severance Hospital. The original drug, Aylia and Alteogen’s biosimilar’ALT-L9′, were administered to 14 patients each. No adverse drug-related reactions were observed in both groups. Maximal corrected visual acuity (BCVA) and central retinal thickness (CST) showed similar improvement effects.
The company said that in this phase 1, it has confirmed the safety and effectiveness of ALT-L9 similar to that of Ilia. It plans to demonstrate equivalence through a follow-up global phase 3 clinical trial.
Aylia is a treatment for wet macular degeneration, one of the elderly blindness diseases. In the U.S. alone, it posted sales of about 5 trillion won last year.
An Alteogen official said, “Ilia biosimilar is a product that can perform phase 1 and 3 clinical trials at the same time due to its characteristics, so it is easy to enter, but it is a product that has a lot of difficulty in launching the product due to its formulation patent. It has firmly established its position as a global first mover with three beats, such as a clinical formulation patent for a production patent,” he said.
Reporter Minsoo Han [email protected]
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