Qilu Pharmaceutical Submits NDA for Aflibercept Intravitreal Injection, China's First Biosimilar Filing

On April 25, Qilu Pharmaceutical announced that the marketing authorization application for its Aflibercept Intravitreal Injection Solution had been accepted by the Center for Drug Evaluation of the National Medical Products Administration. This is the first biosimilar application for this product in China and is expected to be the first generic version to reach the market.

Aflibercept Intravitreal Injection Solution 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. This product is used for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The original drug was approved for marketing in the United States in 2011 and in China in 2018.

In July 2012, Qilu Pharmaceutical initiated the development of aflibercept intravitreal injection solution. After conducting small-scale trials, pilot-scale trials, and commercial-scale production, the research team established a robust manufacturing process. In strict accordance with biosimilar standards, comprehensive quality analyses were performed on the product’s structure, physicochemical properties, and biological activity. The results confirmed that this product is highly similar to the originator drug. Additionally, clinical trial outcomes demonstrated that the product is essentially equivalent to the originator drug in terms of safety and efficacy.

According to the PharmaGo database by PharmCube, besides Qilu Pharmaceutical, the development of this product by Boan Biotech in China has also advanced to Phase III research stage. For patent expiration details of this product, see: Blockbuster Drugs with Patents Expiring in the Next 10 Years (5) — Aflibercept. According to Regeneron's financial report, global sales of Aflibercept reached $9.385 billion in 2021 (+19%).

Recently, the marketing applications of several first generic drugs from Qilu Pharmaceutical have been accepted. On March 22, the marketing application for Qilu Pharmaceutical's Romiplostim was accepted by the CDE for the treatment of immune thrombocytopenia; on March 25, the marketing application for its Riociguat Tablets was accepted by the CDE; and on April 24, the marketing application for Dolutegravir Sodium Tablets was accepted.

In the field of traditional generic drugs, Qilu Pharmaceutical has always been a leader, securing multiple first-to-market generic drugs. According to the company's press release, currently, Qilu Pharmaceutical has 101 products that have passed the consistency evaluation, of which 43 are the first in China. In terms of new drug development, Qilu Pharmaceutical is also making continuous efforts, and has established a rich product pipeline through cooperation and independent research.