BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA).

The drug will reach the China market under the brand name Qletli. Like Humira, which has been available in China since 2010, Qletli is approved to treat indications such as rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

The approval came a little more than a year after Bio-Thera filed a BLA with Chinese regulators for BAT-1406 in August 2018. The candidate entered priority review in November.

"We expect to launch [the drug] in December 2019," Bert Thomas, Bio-Thera's senior vice president of business development, told BioWorld. "Qletli will allow Bio-Thera to start generating revenue from sales while at the same time bring a new affordable therapeutic option to Chinese patients."

Humira is now priced as much as at $2,250 per month in China, which is "far beyond affordable for most patients in China." said Huji Xu, a physician scientist from Tsinghua University. It is not immediately known how Bio-Thera will price its biosimilar to compete with Humira.

Humira was the world's first approved fully human anti-TNF-alpha monoclonal antibody and has been approved for various diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. Last year, the drug hit $19.9 billion in sales worldwide. And since 2010, its total global sales have reached $115 billion.

China, however, has contributed very little to those global sales due to Humira's high price. According to market intelligence provider Frost & Sullivan, the Humira biosimilar market could reach $1.64 billion in China by 2030.

Last year, Bio-Thera said BAT-1406 met its primary endpoint of equivalent efficacy to reference Humira in a phase III trial conducted in patients with active ankylosing spondylitis. The multicenter, randomized, noninferiority, double-blind, controlled trial enrolled 554 patients with ankylosing spondylitis in China.

Among the 554 patients, 363 of them received BAT-1406 and 191 received the reference product. By week 12 of the study, 75.7% of patients in the biosimilar arm had shown an absolute improvement of at least 10 units, compared to 73.7% of patients in the reference arm. The frequency of adverse events between the biosimilar arm and the reference arm was 87.1% and 85.3%, respectively.

With the promising data, Bio-Thera submitted a BLA in China along with a comprehensive data package that consisted of analytical, preclinical and clinical data.

This is China's second approval for a homegrown biosimilar, after Shanghai Henlius Biotech Inc.'s biosimilar referencing Mabthera (rituximab, Roche Holding AG) to treat non-Hodgkin's lymphoma was approved to be marketed as Hanlikang in February. Industry experts expect more homegrown biosimilars to come to the market. (See BioWorld, Feb. 27, 2019.)

Hanlikang is priced at around ¥1,640 (US$235) per 10 mL in China, 32% cheaper than Mabthera.

"The price of Qletli could be around the same as Hanlikang's," Kai Sun, an analyst from Shanghai-based Green River Investment, told BioWorld, who added, "[The approval] is also good news for Bio-Thera's IPO progress."

Bio-Thera is seeking to list as a pre-revenue biotech on Shanghai's high-tech board, known as the STAR board, after the securities regulators accepted its application in July. The drugmaker aims to raise ¥2 billion to advance its drug development programs and build a sales network.

Bio-Thera is also developing biosimilars referencing Avastin (bevacizumab, Genentech, Inc.) and Roactemra (tocilizumab, Chugai Seiyaku Kabushiki Kaisha Corp.), both of which are in global phase III trials, as well as knock-offs of Stelara (ustekinumab) and Simponi (golimumab), of Johnson & Johnson Corp.

The lucrative market that Humira represents is pushing many drugmakers around the world to get their biosimilar versions on the market. To date, the FDA has approved four Humira biosimilars: Amgen Inc.'s Amjevita, Sandoz Inc.'s Hyrimoz, Boehringer Ingelheim GmbH's Cyltezo and South Korea firm Samsung Bioepis Co. Ltd.'s Hadlima. But none has been launched on the market yet.

The race is also fierce in China. Innovent Biologics Inc., of Shanghai, said in August that its IBI-303, a monoclonal antibody with the same amino acid sequence, formulation and route of administration as Humira, had comparable effects in reducing disease activity and improving quality of life and showed a similar safety profile in a phase III trial in China. Zhejiang Hisun Pharmaceutical Co. Ltd.'s HS-016 and Henlius' HLX-03 are also in the commercial-ready stage.

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