Altos Biologics submits EMA Marketing Authorisation Application for aflibercept biosimilar ALT-L9

The Phase III clinical trial for ALT-L9 began in 2022 and incorporated over 400 participants from 12 countries. Image credit: ©aicandy – stock.adobe.com

Altos Biologics Inc. has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept biosimilar. This biosimilar was developed by Alteogen Inc.; Altos Biologics Inc. is a subsidiary of Alteogen.¹

According to the press release from Alteogen¹, the Phase III 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 aflibercept (Eylea) in the indication of wet age-related macular degeneration(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 In the press release, the company also expressed an intent to leverage expertise gained from this trial to develop "a novel multi-specific fusion protein therapeutic incorporating Tie2 regulators, in addition to anti-VEGF mechanisms similar to aflibercept, aimed at stabilising blood vessels."

Reference:

1. Altos Biologics Files Approval of Aflibercept Biosimilar. Alteogen Inc. Published July 1, 2024. Accessed July 2, 2024. https://www.morningstar.com/news/pr-newswire/20240701cn52238/altos-biologics-files-approval-of-aflibercept-biosimilar