Heavy First Imitation! Qilu Pharmaceutical's 'Aflibercept' Filed For Listing

On April 25, Qilu Pharmaceutical announced that the submitted application for marketing authorization of aflibercept intraocular injection solution was accepted by the Center for Drug Evaluation of the State Food and Drug Administration. 

Aflibercept intraocular injection solution is a fully humanized fusion protein, which can block VEGF-A, VEGF-B and PIGF at the same time, and has a wider target; it can more effectively bind VEGF dimer; Longer time and longer lasting effects. This product is used to treat 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 established a project to develop aflibercept intraocular injection solution. The researchers have established a robust production process through small-scale, pilot-scale and commercial scale production, and conducted a comprehensive quality analysis of the product in terms of structure, physicochemical properties, and biological activity in strict accordance with the standards of biosimilars. The original research drug is similar; at the same time, the clinical trial results show that the product is basically the same as the original research drug in terms of safety and efficacy.

According to the PharmaGo database, in addition to Qilu, the product development of domestic company Boan Bio has also advanced to the phase III research stage. Please refer to the patent expiration of this product: Blockbuster drug with patent expiration in the next 10 years (5) - Aflibercept, according to Regeneron's financial report, the global sales of aflibercept in 2021 will reach 9.385 billion US dollars (+19% ).

Recently, the marketing applications of several first generic drugs of Qilu Pharma have been accepted. On March 22, Qilu Pharmaceutical's roprostim marketing application was accepted by the CDE for the treatment of immune thrombocytopenia; on March 25, its riociguat marketing application was accepted by the CDE; on April 24, The marketing application for dolutegravir sodium tablets was accepted.

In terms of traditional generic drugs, Qilu Pharmaceutical has always been in a leading position and has won a number of first generic drugs. According to the company's press release, at present, a total of 101 products of Qilu Pharmaceutical have passed the consistency evaluation, of which 43 are the first in China.