Motivating Generic Drugs from Multiple Points, China is still a Big Generic Drug Country

China has achieved breakthrough progress in terms of the new drug development speed in recent years, however, China started later than the developed countries in Europe and America in drug development, and excellent therapeutics for many diseases were first developed by the developed countries in Europe and America, which, after they are introduced to China, will be quite expensive, among other problems, therefore, generic drugs become a necessary way for Chinese patients to quickly and affordably access those therapeutics. China is still vigorously supporting the generic drug development because China is still a big generic drug country!

It’s reported that generic drugs account for nearly 90% of the overall pharmaceutical market of China. According to the Announcement on Self-inspection and Checking of Drug Clinical Trial Data for Registration Applications (2018, No.30) recently released by SDA (State Drug Administration of China, formerly, CFDA), the number of generic drug reaches 153 among the list of registration applications for 192 pharmaceutical products that have been completed clinical trials and applied for production or import recently received by SDA.

China is constantly increasing the motivation of generic drug development and has successively implemented many incentive measures for generic drugs, so as to further enable Chinese patients to "afford good drugs". For example, the Opinions on Reforming and Improving the Policy for Supply Guarantee and Use of Generic Drugs issued recently proposes to further improve the relevant policy for supply guarantee and use of generic drugs, with measures for implementing such guarantee mainly including:

1. Timely include generic drugs in the procurement catalogue: the centralized procurement of pharmaceutical products needs to be based on the drug procurement catalogue, therefore, timely including generic drugs in the procurement catalogue will help generic drugs equally compete with original drugs;

2. Promote the use frequency of excellent generic drugs: generic drugs generally have no difference with original drugs in terms of efficacy, but have advantages over the latter in terms of price, therefore, departments like the National Health Commission of the P.R.C. should promote the marketing and use frequency of generic drugs through policy incentives, and encourage medical institutions to give priority to purchasing generic drugs.

3. Motive generic drug development and production by using measures such as medical insurance: timely including qualified generic drugs into the medical insurance enables patients to use cheaper generic drugs within the medical insurance system, which will promote generic drug development and production while increasing the generic drug market demand.

However, motivation does not mean indulgence. The relatively loose drug approval and standards for reference preparations in China at the early stage brought many problems left over by history to China’s generic drug market, especially in 2002-2006, the dramatic increase of the number of generic drug application in China resulted in many non-standard low-end generic drugs to flow into the market. Those problems brought many risks to the medication safety of China’s drug market. To address those problems, China started to deliberate on "drug consistency evaluation" in 2012, and officially released the Opinions on Carrying out Quality and Efficacy Consistency Evaluation of Generic Drugs in 2016. Today, more than two years after the implementation, the positive effects of the "generic drug consistency evaluation" policy have received good market responses, and this policy plays a great role in the orderliness and normality of China’s drug market. The relevant drug regulator of China has successively announced four batches of generic drugs of 45 specifications that have passed the consistency evaluation so far.

As China’s generic drugs become normalized and orderly, Chinese drug regulators, enterprises and patients apparently have higher confidence in China’s generic drugs, for example, a certain Chinese drug regulation official has recently point out, "We should take a clear-cut stand in proposing that the purpose of imitation is to substitute. The generic drug substitution is an international rule and practice, and also a requirement of the GFB (2018) No. 20 document (Opinions on Reforming and Improving the Policy for Supply Guarantee and Use of Generic Drugs)."

In fact, the release of no matter the generic drug guarantee policy, "consistency evaluation", or Catalogue of Marketed Drugs in China has the same original intention which is to enable patients to access pharmaceutical products with same efficacy with original drugs but at more preferential prices. The positive changes on China’s generic drug market in recent years are what the patients are pleased to see, especially in terms of the biosimilars, etc., the development of those generic drugs was gloomy for a long time, however, the recent catalogue of medical insurance negotiation has solved the market access and medical insurance payment issues of biological drugs and biosimilars after their marketing in China, and their prospects are generally considered promising. China is still a big generic drug country, therefore, the developments of China’s generic drug market are the focus of the industry. Let’s look forward to a healthier and sounder generic drug market in China!

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