Altos Biologics submits Marketing Authorization Application to the EMA for ALT-L9, an aflibercept biosimilar
The company expects approval from the EMA by 2025.
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Altos Biologics Inc. has submitted the Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept biosimilar. This biosimilar was developed by Alteogen. Altos Biologics Inc. is a subsidiary of Alteogen.1
According to the company’s press release1, the phase 3 clinical trial for ALT-L9 began with initial clinical trial approval in 2022 and incorporated over 400 participants from 12 countries, including those in Europe, South Korea, and Japan. The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet age-related macular degeneration (wet AMD). The primary endpoint of the study was change in best-corrected visual acuity (BCVA) over 8 weeks.
Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics, shared the further plans for this biosimilar in the release1, saying, "Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea."
Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide.1
