Qilu Pharma's Bevacizumab Biosimilar Andakon Receives China’s First Approval with Pricing Disclosed at RMB 1,266 per Vial

On December 14, the Shandong Provincial Drug Centralized Procurement Platform issued the “Notice on Publicizing the Listing of Bevacizumab Injection, a Biosimilar,” announcing the public listing of Bevacizumab Injection (specification: 4 mL:0.1 g) manufactured by Qilu Pharmaceutical, with the proposed listing price set at RMB 1,266 per vial.

Recently, the National Medical Products Administration approved Qilu Pharmaceutical’s marketing registration application for bevacizumab injection. This is the first domestically approved bevacizumab biosimilar in China, primarily indicated for the treatment of patients with advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer.

It is understood that bevacizumab is a humanized monoclonal antibody of the IgG1 subclass, prepared using recombinant DNA technology. By binding to human vascular endothelial growth factor (VEGF), it inhibits the interaction between VEGF and its receptors, thereby blocking angiogenic signaling pathways and suppressing tumor cell growth. As one of the key anti-angiogenic agents in oncology, bevacizumab is utilized in the treatment of various malignant tumors. According to the New Drug R&D Monitoring Database (CPM), bevacizumab has been approved for nine indications, with several additional indications still under clinical investigation.

Ankeda’s approval marks the first domestically developed product in China to use original bevacizumab as the reference drug, following the biosimilar pathway for research, development, and production application. It received support from the National Major New Drug Creation Special Program, and the National Medical Products Administration approved its market launch through the priority review and approval process.

In 2004, Avastin (bevacizumab), the originator drug developed by Roche, was launched in the United States. It achieved global sales of USD 7 billion in 2018, ranking seventh on the list of the world’s best-selling drugs that year. Avastin was approved for marketing in China in 2010 and was included in the National Reimbursement Drug List (NRDL) through price negotiations in 2017, with its price per vial reduced from RMB 5,210 to RMB 1,998. In the latest negotiation results announced on November 28, Avastin successfully renewed its NRDL listing, although the specific price was kept confidential. However, data released by the National Healthcare Security Administration indicated that the average price reduction for the 27 renewed drugs was 26.4%. Based on this figure, the estimated price of Avastin is approximately RMB 1,470.5 per vial or lower.

It is also worth noting that, according to the 2019 regulations of the National Healthcare Security Administration: during the validity period, if drugs with the same generic name (generic drugs) are launched on the market, the healthcare security authorities will adjust the payment standard for such drugs based on the price level of the generics, and may also include the generic name in the scope of centralized procurement. This implies that the healthcare security payment standard for Avastin may undergo another adjustment. From this perspective, the approval and market launch of Ankeda at this time will undoubtedly exert a certain market impact on Avastin.

Not only Agoda, Avastin is also facing a two-pronged attack in both domestic and international markets. In the international market, the FDA has approved two bevacizumab biosimilars: Mvasi by Amgen/Allergan and Zirabev by Pfizer. In the Chinese market, besides Qilu Pharmaceutical, according to the CPM database, there are currently other companies such as Innovent Biologics that have submitted marketing applications for bevacizumab, while some biologics are still in clinical research stages.PharmaceuticalsThere are more than 20 companies.