Domestic generic drugs: "Youth is better than blue"

In the imitation of domestic Entecavir tablets, the innovative construction technology of purine rings is also adopted to effectively avoid complicated chromatographic separation, simplify the post-treatment process, and further reduce production costs while improving product quality.

Consistent evaluation ensures that generic drugs are good and affordable

There has been such a saying on the network: "The purity of the active ingredients of the original and generic drugs is different, one may be 80%-90%, and the other can only achieve 30%-40%." In response to such remarks, Zhang LAN, director of the Pharmaceutical Department of Xuanwu Hospital of Capital Medical University, responded that such rhetoric is completely irresponsible.

"Pharmaceutical equivalence evaluation is an important part of generic drug consistency evaluation in China." Pharmaceutical equivalence requires that generic drugs must have the same active ingredients, content, route of administration and dosage form as the original drug, and meet drug quality standards, Zhang LAN said.

In order to improve the overall level of China's pharmaceutical industry and ensure drug safety and effectiveness, The General Office of the State Council issued the Opinions on carrying out the Consistency Evaluation of the Quality and Efficacy of generic Drugs in 2016, requiring generic drugs to carry out the evaluation of the quality and efficacy consistency of original drugs. Bian Xiaolan, director of the Department of Pharmacy, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, said that the consistency evaluation focuses on verifying that generic drugs are equivalent to the original drugs in terms of design, biological absorption and metabolism, etc. China's generic drug quality and efficacy consistency evaluation has a high starting standard.

On the basis of carrying out consistency evaluation to improve the quality of domestic generic drugs, the state carries out volume collection, so that domestic generic drugs can obtain a fair competition with the original drug. "The drug collection will put generic drugs that pass the consistency evaluation on the same open platform and compete fairly with original drugs." Zhang Ming said that high-quality generic drugs are in great need of a chance to prove themselves in clinical applications.

Data show that after eight batches of national collection, the proportion of patients using high-quality drugs such as original drugs and generic drugs that have passed consistency evaluation has increased from 50% before collection to more than 95%, and the overall quality level of clinical drugs has been improved.

Chang Feng believes that in recent years, China's generic drug industry has made great progress in terms of quality, production capacity and market position. The consistency evaluation policy strictly adheres to the "quality pass" of generic drugs in the approval process, and the number of generic drugs going to sea in China is increasing, and the improvement of international recognition also indicates the improvement of the level of generic drugs in China.

"At present, China is in the stage of leapfrogging from a generic-drug power to a generic-drug power." Chang Feng said that companies on the market that have not passed the consistency evaluation and do not have the advantages of scale production and product pipelines are being eliminated, generic drugs are gradually realizing the high-quality replacement of original drugs, and the concentration of the pharmaceutical industry is constantly improving. On this basis, the quality of medication for Chinese patients will be further improved.