Bloomberg News

China Needs Stricter Rules on Generic Biologic Drugs, Group Says

January 28, 2013

China needs more stringent requirements for approval of generic versions of biologics, complex drugs made from living cells, to ensure their safety and effectiveness, according to an industry report.

Generic copies of biological drugs can be registered as new products in China with fewer testing requirements than originals, according to the report, led by the R&D-based Pharmaceutical Association Committee. The industry group represents drugmakers including Roche Holding AG (ROG) and Pfizer Inc. (PFE:US)

“An abbreviated regulatory process with lower standards poses significant risks on product safety and efficacy,” according to the report, issued today in Beijing. “This regulation framework is inconsistent with global norms and can expose patients to unknown risk.”

China’s market for biologics is about 18 billion yuan ($2.9 billion), or 2 percent of the world’s total, according to the committee. Globally, $25 billion worth of branded biologic drugs will lose patent protection by 2016, facing competition from biosimilars that may have a value of $19.4 billion by next year, according to Dublin-based Research & Markets.

Merck KGaA (MRK) agreed last June to develop lower-cost copies of biotechnology cancer treatments with Indian partner Dr. Reddy’s Laboratories Ltd. (DRRD), while Boehringer Ingelheim GmbH is planning to test a generics version of Roche’s top-selling biological drug Rituxan.

To contact Bloomberg News staff for this story: Daryl Loo in Beijing at

To contact the editor responsible for this story: Jason Gale at

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