The Alteogen Inc. subsidiary company provided an update on its ALT-L9 biosimilar to compete with EYLEA
Alteogen Inc. provided a patient enrollment update for its subsidiary Altos Biologics ongoing Phase 3 study of ALT-L9 for the treatment of neovascular age-related macular degeneration (wet AMD)
According to a release from the company,1 ALT-L9 is an investigational compound intended to be a biosimilar formulation of aflibercept (EYLEA) an anti-vascular endothelial growth factor (VEGF). Altos intends to develop ALT-L9 for the same use as aflibercept with respect to route of administration, posology, and therapeutic indications. According to the release, 1 vial of ALT-L9 contains 11.12 mg of aflibercept (concentration of 40 mg/mL), and the layers of physicochemical and biological assays support the similarity of ALT-L9 to the reference product.
Alteogen is developing ALT-L9 with its strategic alliance partner, Kissei Pharmaceutical of Japan.
According to the release, the Phase 3 trial of ALT-L9 is a randomized, double-masked, parallel group, multicenter study to compare the efficacy and safety of ALT-L9 versus EYLEA in 431 patients with wet AMD.
"Patient recruitment process has been further expedited as Altos Biologics closely communicated with trial collaborators at the local level," Alteogen officials said in the release. "We plan to complete the product approval by the first half of 2025 as biologics license application (BLA) will be submitted to the relevant health authorities in early 2024. Altos Biologics is also making great strides in licensing-out efforts and companies possessing marketing capabilities and a proven track record would be prime candidates in forging partnerships."
According to the company’s website, EYLEA is a biologic with “high market growth potential,” but it is “quite an expensive therapy.” The company aims to launch the competing biosimilar so a “less expensive biosimilar will enable the market to increase by reaching more patients who could not afford Eylea previously.”
The company is aiming for an early 2024 Phase 3 completion and a product launch in Europe after obtaining approval in the first half of 2025, according to the release.