Alteogen's Aflibercept Biosimilar EYLUXVI® Receives Positive CHMP Opinion
Alteogen Inc. recently announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion regarding their newly developed biosimilar, EYLUXVI® (code name ALT-L9). This significant milestone underscores the company's commitment to improving treatment options for patients suffering from various ocular disorders including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).
The positive CHMP opinion is based on a comprehensive data package consisting of analytical, non-clinical, and clinical studies comparing EYLUXVI® with the reference product, Eylea® (aflibercept). Requirements for safety, efficacy, and immunogenicity standards were met following a randomized double-masked Phase 3 study, which involved 431 participants across 79 centers in 12 countries from June 2022 through February 2024. The study demonstrated that EYLUXVI® provided equivalent efficacy to Eylea® with comparable safety and pharmacokinetics.
CEO Soon-Jae Park expressed great satisfaction with this decision, emphasizing its importance for both the company and patients. EYLUXVI®—once approved—will serve as a new treatment option for individuals afflicted with serious eye conditions like wet AMD, offering accessibility to a burgeoning segment of patients who presently have limited alternatives.
EYLUXVI® will be Alteogen's second commercialized biosimilar following the prior licensing of their Herceptin® biosimilar, ALT-L2, which has successfully entered the Chinese market through Qilu Pharmaceutical. The collaboration with Qilu has helped demonstrate Alteogen's capabilities and establish a strong position within the biosimilar market.
The Phase 3 study indicated a primary efficacy endpoint focused on changes in best corrected visual acuity (BCVA), which is crucial for assessing treatment outcomes in patients. The randomized control group design ensured robust comparisons with statistical significance determining the viability of the biosimilar. As the clinical landscape evolves, EYLUXVI® could significantly impact treatment paradigms, driving forward quality and affordability in healthcare for those impacted by retinal diseases.
Established in 2008, Alteogen has quickly emerged as an innovative biopharmaceutical company in South Korea, focusing on developing biologics that include novel therapeutics such as Antibody-Drug Conjugates (ADCs). The recent CHMP recommendation stands out as an indication of Alteogen's strategic direction and highlights the potential of its proprietary platform technologies like NexP™-fusion and Hybrozyme™ technology.
With the global focus on enhancing patient care and the increasing demand for affordable treatment options, EYLUXVI® represents an intersection of innovation and accessibility. As Alteogen navigates the regulatory approval process and moves towards commercialization, stakeholders await the outcomes that will shape the future of ocular disease treatments, particularly in vulnerable populations. The development and delivery of high-quality biosimilars, such as EYLUXVI®, could herald a new era of healthcare where patients have easier access to vital treatments that significantly enhance their quality of life. Consequently, both the biopharmaceutical community and the patients it serves look forward to the establishment of EYLUXVI® in therapeutic usage, and Alteogen's continued commitment to addressing unmet medical needs in this critical area of health.
The positive CHMP opinion is based on a comprehensive data package consisting of analytical, non-clinical, and clinical studies comparing EYLUXVI® with the reference product, Eylea® (aflibercept). Requirements for safety, efficacy, and immunogenicity standards were met following a randomized double-masked Phase 3 study, which involved 431 participants across 79 centers in 12 countries from June 2022 through February 2024. The study demonstrated that EYLUXVI® provided equivalent efficacy to Eylea® with comparable safety and pharmacokinetics.
CEO Soon-Jae Park expressed great satisfaction with this decision, emphasizing its importance for both the company and patients. EYLUXVI®—once approved—will serve as a new treatment option for individuals afflicted with serious eye conditions like wet AMD, offering accessibility to a burgeoning segment of patients who presently have limited alternatives.
EYLUXVI® will be Alteogen's second commercialized biosimilar following the prior licensing of their Herceptin® biosimilar, ALT-L2, which has successfully entered the Chinese market through Qilu Pharmaceutical. The collaboration with Qilu has helped demonstrate Alteogen's capabilities and establish a strong position within the biosimilar market.
The Phase 3 study indicated a primary efficacy endpoint focused on changes in best corrected visual acuity (BCVA), which is crucial for assessing treatment outcomes in patients. The randomized control group design ensured robust comparisons with statistical significance determining the viability of the biosimilar. As the clinical landscape evolves, EYLUXVI® could significantly impact treatment paradigms, driving forward quality and affordability in healthcare for those impacted by retinal diseases.
Established in 2008, Alteogen has quickly emerged as an innovative biopharmaceutical company in South Korea, focusing on developing biologics that include novel therapeutics such as Antibody-Drug Conjugates (ADCs). The recent CHMP recommendation stands out as an indication of Alteogen's strategic direction and highlights the potential of its proprietary platform technologies like NexP™-fusion and Hybrozyme™ technology.
With the global focus on enhancing patient care and the increasing demand for affordable treatment options, EYLUXVI® represents an intersection of innovation and accessibility. As Alteogen navigates the regulatory approval process and moves towards commercialization, stakeholders await the outcomes that will shape the future of ocular disease treatments, particularly in vulnerable populations. The development and delivery of high-quality biosimilars, such as EYLUXVI®, could herald a new era of healthcare where patients have easier access to vital treatments that significantly enhance their quality of life. Consequently, both the biopharmaceutical community and the patients it serves look forward to the establishment of EYLUXVI® in therapeutic usage, and Alteogen's continued commitment to addressing unmet medical needs in this critical area of health.
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