(Health Korea News / Si-Woo Lee) On the 12th, Alteogen announced that it had applied for domestic product approval for ‘ALT-L9’, a biosimilar candidate for Eylea® developed by the company and whose subsidiary Altos Biologics was in charge of global clinical trials and marketing.
Ilia is a blockbuster drug developed by Regeneron for the treatment of age-related macular degeneration (wAMD), which achieved sales of approximately KRW 12 trillion last year. Alteogen said that it had been paying attention to the potential of the product as a biosimilar from early on and had secured competitiveness by applying for and registering various patents.
In the global 12-country phase 3 clinical trial conducted by Altos Biologics, ALT-L9 met the primary evaluation variable and demonstrated therapeutic equivalence to Ilia. Alteogen, which produced, supplied, and conducted initial clinical trials in accordance with laws and regulations, applied for domestic product approval based on the global clinical results.
An Alteogen official said, “In order to launch ALT-L9, we are preparing to apply for approval in many regulatory agencies, including Korea, starting with the application for marketing authorization in Europe,” and “ALT-L9 has already signed a contract with Hanlim Pharmaceutical, the best partner in the domestic ophthalmic treatment sector, and we are systematically preparing a sales plan after approval.”
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