HONG KONG – U.S. regulators have given the green light to 12 biosimilars and the EU has cleared a whopping 53. China, however, has lagged behind, though industry experts are predicting the first biosimilar could clear regulatory hurdles this year.

"By the end of this year, the biosimilar to Roche's Avastin will be the first to be approved in China," said Andrew Yu, director at strategy consultancy Monitor Deloitte's China Life Science Practice, who described China's biosimilars market as "booming."

According to market intelligence provider Frost and Sullivan, the sales revenue of China's biosimilars market will grow at a CAGR of 57.9 percent from 2017 to reach ¥11.4 billion (US$1.66 billion) by 2022.

"Local manufacturers are aggressive when it comes to the entry of biosimilars," Yu added. "They put in huge investment into making biogenerics. There are numerous new plants being built in China."

Avastin (bevacizumab, Roche Holding AG) has caught the attention of most Chinese drugmakers, with 36 of them conducting clinical studies or applying for an IND for their biosimilars.

On Aug. 15, Qilu Pharmaceutical Co. Ltd.'s became the first to seek marketing clearance for its QL-1101, while Innovent Biologics Inc.'s IBI-305, Jiangsu Hengrui Medicine Co. Ltd.'s BP-102, Luye Pharma Group Ltd.'s LY-01008 and Shanghai Henlius Biotech Inc.' HLX-04 are in phase III trials.

Humira (adalimumab), the "drug king" that generates around $16 billion for Abbvie Inc. annually, is another hot opportunity for biosimilars. Among the 29 Chinese companies that are in the biosimilars race, two of them have had marketing applications accepted by the Chinese National Medical Products Administration (NMPA, formerly the CFDA). Bio-Thera Solutions Ltd.'s application for BAT-1406 was accepted on Aug. 20, followed by Zhejiang Hisun Pharmaceuticals Co. Ltd.'s application for HS-016 in September.

"We expect BAT-1406 to be the first Humira biosimilar to be approved for the China market," said Shengfeng Li, CEO at Bio-Thera.

Other candidates in phase III studies include Henlius' HLX-03, Jiangsu Union Biopharma's UBP-1211 and Innovent's IBI-303.

Work will be aided by guidelines issued last month on designing clinical trials for adalimumab biosimilars. That follows similar direction handed down for Avastin and Herceptin (trastuzumab, Roche Holding AG) biosimilars in July and October last year, respectively. Biosimilars makers have to study the pharmacokinetic features, efficacy as well as safety and immunogenicity of their products.

Also coming down the pike are biosimilars of Rituxan (rituximab, Roche Holding AG/Biogen Inc.), with 28 Chinese drugmakers developing biosimilar versions. The NDA filed in October 2017 for Henlius' HLX-01 was the first application for a biosimilar to be accepted by the NMPA. Innovent's IBI-301, Hisun's HS-006 and Sinocelltech Ltd.'s SCT-400 are at phase III stage.

Meanwhile, 21 Chinese drugmakers are developing Herceptin biosimilars, which include Henlius' HLX-02, Genor Biopharma Co. Ltd.'s GB-221 and Hisun's biosimilar, all of which are in phase III trials. So far, no Chinese companies have filed an NDA for a Herceptin biosimilar.

Stepping up the game

With the first biosimilar soon to enter the China market, David Li, head of China and Hong Kong Healthcare at CLSA, said China is switching to biologics.

"Most of the bestselling drugs in China are traditional Chinese medicine and adjuvant drugs. But the industry is undergoing upgrading, so we expect to see the best-selling drugs in China to be biologics in the near term," Li said at CLSA's annual investors' forum in Hong Kong.

Foreseeing that trend, back in February 2015 the NMPA published the Guidelines on Development and Evaluation of Biosimilars, with the aim of encouraging domestic players to pump out biosimilars to meet demand for affordable biologics.

The demand for cheaper drugs has been driving the development of biosimilars in China, where biologics are mostly expensive imported originals not covered by healthcare insurance.

"Chinese players are now spending more on research and development of innovative drugs," Li said.

But he noted that the R&D spending ratios of Chinese pharmaceutical companies still lag those of global peers. On average, they spend 7.9 percent of their revenues on R&D vs. a 20.9 percent average worldwide.

On that basis, foreign drugmakers could still gain an upper hand in the biosimilars race in China.

"China's market opens an opportunity window for multinational biosimilar makers who make good enough products at a more affordable price," Monitor Deloitte's Yu noted.

He added that biosimilars are not as easy to make as small-molecule drugs. It requires technical know-how. And the concern among some Chinese physicians is whether or not local biosimilars can reach the quality standard of the originators.

"However, we believe the Chinese companies will catch up fairly quickly given the favorable policy environment and sufficient funds to acquire techniques and assets in either China or the global market," Yu said.

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