Qilu Pharmaceutical's Aflibercept Intravitreal Injection Approved as China's First Biosimilar
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Aflibercept, jointly developed by Regeneron and Bayer, is a vascular endothelial growth factor (VEGF) inhibitor that binds to VEGF-A and PlGF, thereby inhibiting their binding and activation of VEGF receptors. It is currently mainly used for neovascular (wet) age-related macular degeneration, retinal vein occlusion-associated macular edema, and diabetic macular edema. In 2011, aflibercept was approved for marketing in the United States and officially entered the Chinese market in 2018. In August this year, the new version of aflibercept 8mg (administered once every four months), jointly launched by Bayer and Regeneron, was also approved for marketing by the FDA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
In terms of sales performance, according to Bayer's financial report, the sales revenue of Aflibercept reached 3.213 billion euros in 2022, increasing by 10.1% year-on-year. Regarding the performance in the Chinese market, data from Pharma Intelligence shows that the sales revenue of Aflibercept in Chinese hospitals increased year by year from 2018 to 2022, reaching 694 million yuan in 2022, with a four-year compound annual growth rate of 125%. It is expected to continue to grow in the future.
Image Source: Yaoke Network
Another noteworthy point is that the original patent for Aflibercept will expire in 2025. Currently, multiple companies in China are also making strategic moves, including Qilu Pharmaceutical, Boan Biotech, and Mabwell Biotech, with some already advancing to phase three clinical trials.
Text | Medical Valley
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