China needs more stringent rules for approval of less expensive versions of biologics, complex drugs made from living cells, to ensure their safety and effectiveness, according to an industry report.
Less costly copies of biological drugs currently are allowed to be registered as new products in China with fewer testing requirements than originals, according to the report led by an industry group, the R&D-based Pharmaceutical Association Committee. The Beijing-based group represents drugmakers including Roche Holding AG and Pfizer Inc.
“An abbreviated regulatory process with lower standards poses significant risks on product safety and efficacy,” the group said in the report issued today. “This regulation framework is inconsistent with global norms and can expose patients to unknown risk.”
The report on the development of China’s biologics industry urged the government to encourage more funding sources for patients, including the introduction of commercial health insurance. That would improve access to more expensive biologic drugs, according to the report.
“It would be great progress if we can put the more effective and economically viable innovative biological drugs onto China’s subsidized drugs list,” Penny Wan, general manager of Roche Holding’s China unit, said at a briefing in Beijing.
Other ideas include cost-sharing by the government, companies and patients to make such drugs more affordable, said Wan, who is a member of RDPAC’s executive committee.
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 lower-cost copies, known as biosimilars, that may have a value of $19.4 billion by next year, according to Dublin-based Research & Markets.
Merck KGaA agreed in June last year to develop lower-cost copies of biotechnology cancer treatments with its Indian partner, Dr. Reddy’s Laboratories Ltd. Boehringer Ingelheim GmbH plans to test a cheaper version of Roche’s top-selling biological drug Rituxan.