Alteogen Receives Positive CHMP Opinion for Aflibercept Biosimilar, EYLUXVI(R).

Alteogen has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its biosimilar product EYLUXVI (ALT-L9), referencing Eylea (aflibercept). The CHMP opinion is based on a robust analytical, non-clinical and clinical data package. Upon approval, EYLUXVI will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license partner Qilu Pharmaceutical. EYLUXVI has been recommended for approval in adult patients for various ocular diseases.

Alteogen Inc. (KOSDAQ:196170), a South Korea-based biopharmaceutical company, has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its biosimilar product EYLUXVI® (code name: ALT-L9). This opinion, based on a robust analytical, non-clinical, and clinical data package, paves the way for EYLUXVI® to become the company's second biosimilar product following its Herceptin® biosimilar, developed by its license partner Qilu Pharmaceutical.

EYLUXVI®, a biosimilar referencing Eylea® (aflibercept), has been recommended for approval in adult patients for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch [RVO] or central [RVO]), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

The positive CHMP opinion was derived from a comprehensive analytical, non-clinical, and clinical data package, including a randomized, double-masked, parallel group, multicenter Phase 3 study conducted by Alteogen Biologics. This study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between EYLUXVI® and the reference aflibercept in patients with wet AMD.

If approved, EYLUXVI® will be a significant addition to Alteogen's portfolio, providing a new, accessible treatment option for patients suffering from various ocular diseases. This approval marks a significant milestone for the company, which focuses on the development and commercialization of novel biologics, including Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars.

References:
1. [Alteogen Receives Positive CHMP Opinion for EYLUXVI®](https://www.prnewswire.com/news-releases/alteogen-receives-positive-chmp-opinion-for-aflibercept-biosimilar-eyluxvi-alt-l9-302514688.html)
2. [Alteogen Receives Positive CHMP Opinion for EYLUXVI®](https://finance.yahoo.com/news/alteogen-receives-positive-chmp-opinion-060000562.html)