BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).
Ankada is the third China-developed biosimilar to get the marketing nod this year, after Shanghai Henlius Biotech Inc.'s Hanlikon, referencing Roche’s Mabthera (rituximab, Roche), and Bio-Thera Solutions Ltd.'s Qletli, referencing Humira (adalimumab, Abbvie Inc.). China has opened the door to more homegrown biosimilars this year.
Qilu was the first company to seek approval for a bevacizumab biosimilar in China. Last year in August, China’s National Medical Products Administration (NMPA) accepted the company’s NDA, putting QL-1101 on the priority review pathway two months later.
The company told BioWorld that since the approval has just been granted, it will take a week or two to reveal further details about launch plans. But industry analysts already expect the homegrown biosimilar will drive down prices in China and put pressure on the multinational players.
“Innovent Biologics Inc. and Tot Biopharm Co. Ltd. are coming up next in the [bevacizumab biosimilar] race. In the mid-term, we will see just how much Roche wants to get its originator drug on the national reimbursement drug list next year. In the long run, all players will lower the prices of their products,” Li Yishi, executive director of Haoyue Capital, told BioWorld.
Avastin has been the most widely used anti-VEGF monoclonal antibody in the world since its entry into the market in 2004. It first entered the China market in February 2010 for use in combination with 5-fluorouracil-based chemotherapy to treat mCRC, then won another approval for treating NSCLC in 2015.
In 2017, Roche negotiated with the Chinese authorities to add it to the national reimbursement drug list for ¥1998 (US$283.8), 62% lower than its original price at ¥5210. This year, Avastin again secured a place on the updated list for an undisclosed price.
But as a biosimilar version is now approved, more price talks for Avastin might be required with the Chinese insurance authorities in the near term to adjust its price on the list after Qilu reveals Ankada’s price.
According to Frost & Sullivan, bevacizumab was the fourth best-selling oncology drug in China last year. The sales revenue of bevacizumab in the country were ¥3.2 billion in 2018 and are expected to reach ¥13.1 billion in 2023 and ¥17.7 billion in 2030.
In particular, the sales revenue of bevacizumab biosimilars is expected to grow at a compound annual growth rate (CAGR) of 343.5% from 2019 to approximately ¥6.4 billion in 2023, and further grow at a CAGR of 6.5% to reach ¥9.9 billion in 2030, outperforming the originator drug.
The numbers reflect the rapid market expansion as Chinese patients’ incomes improve and drugs become cheaper. Potentially, drugmakers with affordable bevacizumab biosimilars, such as Qilu, may benefit from the increasing market penetration, enjoying higher sales volume and revenue despite a reduction in the price.
“This trend is particularly beneficial to first movers of biosimilars given the originators have educated the market and established recognition among patients and physicians in terms of its efficacy and safety,” Frost & Sullivan said.
And yet more drugmakers are aiming for first-mover advantages. Following expiration of the patent for bevacizumab in China in July, the competition to pump out bevacizumab biosimilars has only become fiercer. To date, 13 bevacizumab biosimilar drug candidates have completed or reached phase III trials.
The second forerunner after Qilu is Innovent, which said in January that Chinese regulators have accepted an NDA filing for IBI-305 in NSCLC. Innovent revealed last year that its clinical trials of IBI-305 have met primary endpoints.
Tot Biopharm’s TAB-008 is also nearing the NDA stage. The drugmaker plans to complete the phase III trials by the end of this year and submit an NDA in March or April of 2020. It expects to launch TAB-008 between late 2020 and early 2021.
Other competitors in the race include Beijing Mabworks Biotechnology Co. Ltd.’s MIL-60, Bio-Thera Solutions Ltd.'s BAT-1706, Genor Biopharma Co. Ltd.'s GB-222, Luye Pharma Group Ltd.'s LY-01008, Henlius' HLX-04, Jiangsu Hengrui Medicine Co. Ltd.'s BP-102, Chia Tai-Tianqing Pharmaceutical Co. Ltd,’s TQ-B2302, Hualan Genetic Engineering Co. Ltd.’s WBP-264, Sinocelltech Ltd.’s SCT-510 and Ankebio’s AK-3008.
Henlius plans to file an NDA in 2020 and Luye expects to market its version in 2021.
To date, Avastin has been approved for multiple indications in the U.S. and EU, including glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and breast cancer. Chinese drugmakers believe the country’s regulators will similarly approve new indications in the future.