Qilu Pharmaceutical's Bevacizumab Biosimilar Nears Market Launch, Set to Disrupt China's Multi-Billion-Dollar Oncology Drug Market

Roche’s Bevacizumab $40 Billion Market to Face Impact.

Public data shows that on August 15, the Center for Drug Evaluation (CDE) of the China Food and Drug Administration has accepted Qilu Pharmaceutical's Class 2 new drug marketing application for its recombinant humanized anti-VEGF monoclonal antibody injection (bevacizumab). The first biosimilar of bevacizumab may accelerate its market launch.

According to further inquiries by Jian Shi Jun, in addition to Qilu Pharmaceutical, since 2016, Innovent Biologics and Shanghai Henlius Biotech (a subsidiary of FosunPharmaceuticals), and the bevacizumab products from eight companies, including 3SBio Inc. and Bio-Thera Solutions, have long since submitted clinical trial applications, which have been accepted by the CDE.

In recent years, China has intensified its support for the research and development of biosimilars. In the "Measures for the Administration of Drug Registration (Revised Draft)" issued by the national drug regulatory authorities in July 2016, the concept of biosimilars was standardized, and it was proposed for the first time that “during drug approval, key attention should be paid to the similarity in quality and efficacy between biosimilars and the originator drugs.”

Industry experts point out that, supported by national policies encouraging innovation in pharmaceuticals and medical devices as well as the development of biosimilars, domestic enterprises are expanding into the biologics sector. Imported biologics, represented by bevacizumab, will gradually lose their exclusive advantage, and the hundred-billion-yuan anti-tumor drug market will also be impacted.

Qilu Sprint

Leading Innovent Biologics, Fosun Pharma, and others

Qilu Pharmaceutical’s recombinant humanized anti-VEGF monoclonal antibody injection (bevacizumab) is positioned to compete with Avastin, one of Roche’s three blockbuster drugs. First approved in the United States in 2004, the drug was initially indicated for the treatment of advanced colorectal cancer. With continuous expansion of its indications, it has gradually become the first anti-angiogenic agent widely used in the treatment of advanced cancers, covering colorectal cancer, breast cancer, lung cancer, renal cell carcinoma, brain cancer, and ovarian cancer. According to statistics, its global sales in 2017 were approximately USD 7 billion, equivalent to RMB 49 billion.

After its launch in China in 2015, although only two indications—colorectal cancer and non-small cell lung cancer—were approved, Avastin still achieved a relatively rapid sales growth. According to statistics, the sales revenue of this product in domestic sample hospitals exceeded RMB 500 million in 2017, with estimated terminal sales reaching approximately RMB 1.5 billion.

In 2017, Avastin was also included in the National Reimbursement Drug List through price negotiations, with a 62% price reduction—from RMB 5,210 per vial to RMB 1,998. Industry analysts predict that, as insurance policies continue to be implemented and indications expand, the market share of this product will exceed RMB 5 billion in the future.

However, Avastin may not be able to fully capture this benefit on its own.

With the aim of reducing drug markups and improving patient access to medications, China has been promoting the clinical substitution of originator drugs across various stages of medical insurance and drug procurement. (See: “National Healthcare Security Administration’s Drug Procurement Pilot to Launch, Generics to Dominate 70% of the Market!”) On this basis, biosimilars from companies such as Qilu Pharmaceutical, Innovent Biologics, and Fosun Pharma will undoubtedly become formidable competitors to Avastin.

Uneven Force Application

Crowded R&D on Popular Targets

Biosimilars are often described as having “large market potential, high barriers to entry, and limited price reductions,” and are also key products encouraged for research and development by the state.

In February 2015, the China Food and Drug Administration (CFDA) issued the “Technical Guidelines for the Research and Evaluation of Biosimilars (Trial),” encouraging and regulating domestic pharmaceutical companies to engage in the research, development, and regulatory submission of biosimilars.

In July 2016, the “Administrative Measures for Drug Registration (Revised Draft)” released by the national drug regulatory authorities first proposed that “during drug approval, key attention should be paid to the similarity in quality and efficacy between biosimilars and the originator drug.”

Last October, as the patent for Roche’s another blockbuster drug, Herceptin (trastuzumab), was about to expire, the Center for Drug Evaluation (CDE) issued a special “call for heroes” to recruit and support domestic enterprises in actively developing biosimilars of trastuzumab. This product had total sales of nearly $7.5 billion in 2017.

Data from the Forward Industry Research Institute shows that as of December 2017, a total of 179 companies in China had applied for clinical trials of monoclonal antibodies and Fc fusion proteins. R&D efforts were heavily concentrated on popular targets such as VEGF, TNF-α, EGFR, CD20, HER2, and PD-1/L1. Roche’s three blockbuster drugs—bevacizumab, rituximab, and trastuzumab—were all key focuses of corporate R&D.

Among them, there are more than 20 PD-1 inhibitors alone, making it another explosion point following the "interferon boom" and the "tinib explosion."

Analysts believe that the current situation is directly attributable to insufficient cognition and judgment among domestic enterprises, as well as the influx and favor of capital. Such homogenized competition is bound to lead to vicious rivalry, resulting in mutual detriment and even driving out high-quality products with inferior ones (“bad money drives out good”), thereby preventing truly innovative drugs from achieving their due returns.

Source: Jian Shi Ju

Author: Chriss