Qilu Pharmaceutical's Aflibercept Ophthalmic Injection Approved as China's First Biosimilar

On December 18, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical's aflibercept intravitreal injection solution has been approved for marketing. This is the first biosimilar of aflibercept to be approved in China.

The original research aflibercept intravitreal injection solution, jointly developed by Bayer and Regeneron, is a fully humanized fusion protein that can simultaneously block VEGF-A, VEGF-B, and PIGF, with a broader range of action targets. It can bind more effectively to VEGF dimers and has a longer duration of action, providing more sustained efficacy. Since its first approval in the United States in 2012, this intravitreal injection has gained multiple indications, including macular edema secondary to retinal vein occlusion, myopic choroidal neovascularization, diabetic macular edema, wet age-related macular degeneration, diabetic retinopathy, glaucoma or ocular hypertension, and retinopathy of prematurity.

In addition, the new version of Aflibercept 8mg jointly launched by Bayer and Regeneron was approved by the FDA for marketing in August this year, for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

It is reported that the expiration time of the core patent for the original drug Eylea (Aflibercept) is 2025-2026. According to the PharmaCube database, in addition to Qilu Pharmaceutical, several other leading domestic companies such as Boan Biotech, Mabwell, and Genzer Biotech have also advanced this product to Phase III clinical trials.

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