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Analysis on the progress of the consistency evaluation of generic drugs in 2020

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After several years of development, the consistency evaluation of generic drugs has made some progress. As of August 2020, 600 companies across the country have actively participated in the evaluation, and a total of 533 varieties and 2,319 drugs have been accepted. With the continuous deepening of consistency evaluation, local development will face more fierce competition and challenges, but at the same time, it will also be full of new opportunities to seize the market and force industrial transformation and upgrading.

The process of consistency evaluation of generic drugs

More than 90% of China’s drug market has been dominated by generic drugs for a long time. The quality of generic drugs is closely related to people’s health. However, domestic generic drugs are of low quality and poor efficacy, and national health is difficult to protect. It is urgent to rectify the generic drug market. On the basis of fully studying the domestic pharmaceutical market and learning from the reform policies of the pharmaceutical industry in developed countries, the domestic generic drug consistency evaluation policy came into being.

In 2012, the state put forward a plan to carry out the consistency evaluation of generic drugs, requiring comprehensive improvement of the quality of generic drugs, so that generic drugs and original drugs can achieve the same therapeutic effect;

In 2016, the plan was officially launched, and the consistency evaluation of oral solid preparations was launched first;

In 2020, the consistency evaluation of injections will be officially launched, and the consistency evaluation work will continue to deepen.

At present, the consistency evaluation of generic drugs is still aimed at chemical generic drugs, the evaluation guidelines for biosimilar drugs are still in the trial stage, and many evaluation principles still need to be perfected in practice.

The introduction of the consistency evaluation of generic drugs ensures that generic drugs are consistent with the original drugs in terms of quality and efficacy, and are clinically replaced with original drugs. This is not only conducive to saving medical costs, but also helping to improve the quality of my country’s generic drugs and the pharmaceutical industry. The overall level of development to ensure that the public’s medication is safe and effective.

Overview of the progress of consistency evaluation of generic drugs

The number of generic drug acceptances exceeded 2,300, and competition among popular large-variety companies was unprecedentedly intense.

Since the publication of the “Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs” in 2016, major generic drug companies have responded positively. As of the end of August 2020, there are a total of 533 varieties of marketed generic drugs and 2,319 product applications have been accepted.

The top three declared varieties are: Amoxicillin Capsules, Ceftriaxone Sodium for Injection and Amlodipine Besylate Tablets. Among them, Amoxicillin Capsules and Ceftriaxone Sodium for Injection are ranked first in the number of declarations, both of which are 55. However, the number of competing companies for amlodipine besylate tablets reached 41, and the competition was unprecedentedly fierce.

The number of consistency evaluation companies reached 600, with Qilu, Kelun, and CSPC among the top.

As of the end of August 2020, there are 600 companies applying for consistency evaluation (differentiating from the parent company and its subsidiaries). Among them, the company with the largest number of applications is Qilu Pharmaceutical (the parent company), and the number of approvals has reached 61, involving 43 drug varieties.

From the perspective of enterprise declarations, large-scale generic drug companies have established relevant subsidiaries to actively deploy to promote consistency evaluation and seize the market. For example, Kelun Pharmaceutical and its seven subsidiaries have applied for 78 approval documents, and CSPC relies on the following four A total of 59 approval documents were applied by the subsidiaries.

The clinical trials are advancing steadily, and the clinical trials of generic injections are concentrated

As of the end of August 2020, CDE registered generic drug clinical trials have completed and ongoing projects reached 1290, of which 911 projects have been completed, mainly focused on chemical injection generic drugs, the top five are all injections, respectively for injection Ceftriaxone Sodium, Ambroxol Hydrochloride Injection, Parecoxib Sodium for Injection, Ceftazidime for Injection, Omeprazole Sodium for Injection.

The Yangtze River Delta is strong, and Jiangsu Province ranks first in the number of generic pharmaceutical companies

Focusing on 600 high-quality generic drug companies that applied for consistency evaluation, from a national perspective, 29 provinces, municipalities, and autonomous regions have high-quality generic drug companies. The companies are mainly distributed in Jiangsu, Guangdong, Shandong, Zhejiang and other regions. The number of companies in the above four provinces is It accounts for more than 36%, among which the number of generic pharmaceutical companies in Jiangsu Province has reached 73, ranking first.

Analysis of Local Development Path Opportunity under the Status of Consistency Evaluation

The promulgation of the consistency evaluation has brought challenges and opportunities to the chemical medicine industry in various regions. Under the current situation, the local development path can be developed from the following aspects:

Encourage enterprises to actively participate in consistency evaluation and respond to national policy reforms

In response to the country’s continuous deepening of policies such as volume procurement, local governments must first encourage companies to actively participate in generic drug consistency evaluations and provide corresponding subsidies; second, they must promote the construction of large-scale C(D)MO platforms and comprehensively control production Cost, flexible response to the shortlisted results of volume purchases, and production outsourcing under the MAH system to avoid loss of production capacity.

Specific measures are shown in encouraging local large-scale and powerful pharmaceutical companies to independently build C(D)MO platforms, and the government provides corresponding subsidies; or local governments take the lead in building C(D)MO platforms and introduce third-party business operations.

Encourage companies to deploy high imitation, first imitation, and difficult imitation drugs

For areas with a good corporate foundation, companies can be encouraged to actively expand product lines, especially those that are urgently needed for clinical use and have a large market, and support the development of high- and hard-to-follow and first generic drugs, relying on local generic drugs stock companies and introduced increments Enterprises, carry out imitation development of drugs that are urgently needed for clinical use, shortage of supply, accurate curative effect, and expired new patents, to improve the accessibility of patients to medication, enhance the competitiveness of enterprises, and seize new markets.

Guarantee the supply of upstream APIs and promote the upgrading and transformation of enterprises

Adequate supply of generic APIs is crucial to the development of the generics industry. For areas with a good API basis, local API companies can be encouraged to develop special APIs and patented APIs related to high-end generics and patented generics. , And encourage enterprises to upgrade and transform into a generic pharmaceutical preparation company.

For areas where the supply of APIs is insufficient and the development of the API industry is limited, support for the cross-regional API-preparation integration industry layout and help companies open up import channels to ensure the supply of APIs for local generic drug companies.

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