Efficacy and safety backed by study looking at China's bulk-buying program

Generic drugs from China have proved as safe and effective as their branded counterparts in real-world studies, and the country's generic medicine sector has improved in quantity and quality in recent years, experts and officials said last week.

A study led by the National Healthcare Security Administration evaluated 23 types of medicines involved in the second and third rounds of the national centralized procurement program, covering drugs used to fight infection and treat cancers and metabolic, endocrinological, mental health, cardiovascular and digestive conditions.

"We found that the efficacy and safety of these drugs are parallel to those of branded drugs," Zhang Lan, the director of pharmacology at Capital Medical University's Xuanwu Hospital and the head of the two-year study, said at a news conference where it was released on Oct 17.

China launched the first round of its bulk-buying initiative in 2018 and has rolled out seven more since. Designed to reduce the cost of expensive drugs and alleviate the financial pressure on patients, the bulk purchases have covered 333 types of medicines.

The majority of the drugs are generic versions of name-brand products, and that led to some concerns about their efficacy and safety among some patients and medical workers.

To dispel such concerns, the administration rolled out its first study in 2019 to measure the efficacy and safety of 14 types of drugs selected during the first round of the procurement program. The study reached the same conclusion that generic medicines are as safe and effective as their name-brand counterparts.

Zhang said some treatment outcomes did vary between patients and it was possible that a certain ratio of patients would find a particular drug less effective than expected.

"It is unreasonable to jump to the conclusion that generic drugs are inferior to their branded counterparts based on a few sporadic cases," she said. "Only through studies of a large population can we arrive at a scientific conclusion."

She added that a third study — focusing on the fourth and fifth rounds of drugs included in the central bulk-buying program — began last month.

A conformance evaluation system for generic drugs was introduced in 2016, and passing the evaluation means that a generic drug has the same active ingredient, dosage form, method of administration and therapeutic effects as its branded counterpart.

Because all drugs considered for inclusion in the national procurement must pass a conformance evaluation, drug manufacturers have become more active in seeking such appraisals, leading to an overall improvement in generic drug quality in recent years, said Zhang Ming, an expert in drug procurement with the administration.

"The centralized procurement program has pushed drugmakers to invest less in marketing and focus more on producing drugs that have never been made into a generic version or are hard to replicate," he added.

Chang Feng, dean of the School of International Pharmaceutical Business at China Pharmaceutical University, said the number of generic drugs that had passed conformance evaluation had grown to over 3,900 by the end of last year.

"From 2010 to 2014, the average number of certifications gained by Chinese generic drugmakers in the United States was 20. In 2020, the number grew to over 80," he added.