Will the range of varieties of consistency evaluation be further expanded?

Medicine network May 26 - Consistency evaluation of the range of varieties will be further expanded?Voices of the two sessions: the establishment of scientific consistency evaluation standards and monitoring measures for special drug types such as biologics and biosimilars2020, according to theTimes reported that the National Committee of the Chinese People's Political Consultative Conference(CPPCC), Fengtai District Fangzhuang Community Health Service Center Director Wu Hao suggested:before the steady expansion of the collection of drugs, recommended that the State Administration of Quality Supervision and Administration of biological agents, biosimilars and other special drug types set up scientific consistent evaluation standards and supervision measures, so as to help patients reduce the burden of medication at the same time to protect the safety of patients, give full play to the national health insurance bureau strategic purchase advantagesup to now, China's generic drug consistency evaluation work presents the first oral preparation of chemical drugs, injection forms followed by the development trendThe remaining types of drugs - Chinese medicine, biological medicine, whether to carry out the corresponding evaluation methods to improve quality standards has become the focus of the industryRecalling the course of carrying out the conformity evaluation of generic drugs in China is as follows:August 18, 2015, the State Council's Opinion on Reforming the Review and Approval System of Drugclearly stipulates: to improve the quality of generic drugs, and to speed up the consistent evaluation of the quality of generic drugsMarch 5, 2016, the General Office of the State Council on the implementation of the quality and efficacy of similar drugs consistent evaluation of the opinion" officially released, marking the official beginning of the consistency evaluationMay 12, 2020, the State Drug Administration "on the implementation of chemical injection generic sumosome quality and efficacy consistency evaluation" (No62, 2020) issued, the official launch of the chemical injection consistency evaluation order gunaccording to the provisions of the State Drug Administration, the time limit requirement for consistency evaluation is - "the new registration classification of chemical strains approved before the implementation of the list of generic drugs including essential drug varieties, since the first variety through the consistency evaluation, the same varieties of other drug productionshould in principle be completed within 3 years of consistency evaluation."Seiberblue consulted a number of professionals on whether biologics would conduct a consistency evaluation Beijing Dingchen Management Consulting Center founder Shi Lichen said today to Seiberblue, China has not done a consistent evaluation of generic drugs, which determines that China's consistency evaluation work must go step by step, because whether it is the enterprise level or the regulatory level, need a process of accumulation of experience the reason for the oral preparation is first because the consistency evaluation of oral preparations in all is relatively easy, and now progress to the consistency evaluation of chemical injections, after the biological preparations, Chinese medicine preparations will carry out the corresponding evaluation of the quality level of drugs Dong Lei, general manager of Tiandong Pharmaceuticals, also said that the current consistency evaluation of biochemical drugs has begun, biologics also need to be consistent evaluation However, Dong pointed out that biosimilar drugs and biologics are complex and have many specific criteria to be refined it is worth noting that there are precedents in the world for consistent evaluation of biological drugs - on May 10, 2019, the FDA completed and issued a biosimilar drug-based alternative guide, providing biosimilar drug companies with a clear path to prove that their products have an alternative relationship with the original drug in accordance with the logic of China's drug regulatory system to Europe and the United States, the domestic consistent evaluation of biological drugs is also a high probability event 　　However, Mr Slichen points out that this may take a long time, after all, it will take a long time to raise the quality level of medicines in a country - only after the consistency evaluation of oral and injectable formulations is basically completed but from the current point of view, the domestic consistency evaluation progress is still relatively slow, mainly because of the limited BE institutions, consistency evaluation costs are high, which determines that the majority of drug companies involved in the consistency evaluation work is a very small number of pharmaceutical companies, the majority of the remaining pharmaceutical companies, perhaps in the next 5-10 years, gradually out on the consistency evaluation of biological agents, Cypress Blue also heard a different point of view - Chongqing Pharmaceutical Co., Ltd President Assistant Lei Huangshu to Seiber Blue pointed out that the establishment of a consistent evaluation standard for biosimilar drugs, such as biological similar drugs is difficult, biological similar drugs and small molecule drugs are not the same, research difficult, while in the process of research and development has been consistent and similar evaluation comparison, but biological similar drugs are difficult, unlikely to do exactly the same Seiber Blue special author Wang Bo also said that biosimilardrugs can not be like chemical drugs to carry out consistency evaluation, because it is not a difference in composition, but different production process, targets and pathways are the same The Thunder further said that he personally believes that biological drugs do not necessarily need to carry out a consistency evaluation, in the approval of strict checks to see if similar to the reference drugs can be in general, whether it is the consistency evaluation of chemical drugs or the re-evaluation of Chinese medicine preparations, or nMPA for biological agents issued the experimental guidelines behind the relevant departments to ensure the quality of drugs, reduce drug prices, the appeal can not be ignored.