Biosimilars cannot replicate the original drug and are not similar.

AuthorThere is a type of cancer that, after 30 years of unremitting efforts, is successfully transforming from a terminal illness to a "chronic disease"there is no doubt that it is breast cancersince 1998, the first target of Her2 humanized monoclonal antibody - qutodzumab (commodity name: Herceptin) came out, changed the prognosis of Her2-positive breast cancer patients, affected the diagnosis and treatment of breast cancer model, is a major breakthrough in breast cancer drug treatment2019 the second breast cancer monoclonal targeted drug patozumab (commodity name: Patet) officially launched in Chinareviewing the existing evidence-based medical evidence, the qurillazumab anti-combination "Hepa double target" program has run through the early new auxiliary, auxiliary treatment and advanced first-line treatment, is recognized as the treatment standard of HER2-positive breast cancer patients at home and abroadWith the fierce competition in the breast cancer drug market, chemical generics and biosimilars are emerginghow to regulate the clinical drug use of biosimilar drugs in China, to help doctors and patients to correctly understand the emerging concept of biosimilar drugs is particularly importantgrasp the certainty of the problem is the cure that Her2 was discovered in the 1980s and later found in breast cancer as the expressed Her2 proteinit was found that her2 gene amplification was one of the most important factors affecting breast cancer growth and metastasisoverexpression of the Her2 gene isabout 30% of breast cancers, associated with poor patient prognosisHer2 became a clear prognostic indicator of breast cancer and a predictive indicator of drug treatment, prompting scientists to continue to explore the clinical application value of the genein the four subtypes of breast cancer, Her2-positive breast cancer is a more dangerous type of molecular subtype, breast cancer about 25% of Her2-positive breast cancer, with HER2 overexpression as a feature, with a high degree of malignant tumor, prone to lymph node metastasis, high recurrence metastasis, poor prognosis characteristicsWith the further study of Her2, scientists recognize that the Her2 gene is a prognostic indicator of clinical treatment monitoring and an important target for tumor-targeted drug selectionbreast cancer treatment has been improving in recent yearstraditional breast cancer treatment treatment includes eradication therapy (mastectomy and even peripheral lymph node removal), chemotherapy, radiotherapy, endocrine therapy, etc., but patients are prone to metastasis, recurrence, patients have poor prognosis1998, after the market of qutodzumab, breast cancer opened the era of precision targeted treatmentat the Breast Cancer Conference san Antonio Breast Cancer Conference, an authoritative study showed that 75 percent of early patients can survive more than 10 years through chemotherapy and a standard one-year standard complementary treatment of querceontumor molecular target therapy is the use of tumor cell expression while normal cells are rarely or unexpressed specific genes or gene expression products as therapeutic targets, to maximize the killing of tumor cells, and less than normal cells to kill the treatment modelto verify the complementary treatment of patozumab and quralmon and chemotherapy combined with early breast cancer, a six-year follow-up data from a study called APHINITY were jointly conducted in several countries around the world: the risk of recurrence decreased by 23% in the ITT population, an absolute benefit of 2.8%, to the high-risk population of lymph node-positive, for example, the survival rate of non-permeable recurrence was nearly 88% and the absolute benefit reached 4.5%2019St Gallen Consensus recommends the preferred "Hepa Double Target" auxiliary treatment for patients in stage II to III, regardless of hormone receptor statusbiosimilars are similar to the original research drugs, but by no means the same with the competitive competition in the breast cancer drug market, generic drugs, biologically similar drugs are emergingcoupled with the expiration of the patent of biogenic drugs, but also make biological-similar drugs to get the opportunity to market, how to safely, effectively, objective understanding of biological-similar drugs, domestic academic circles also have a corresponding discussion and consensusbiosimilars are a kind of biological drugs, compared with small molecular chemicals, biological products have relative molecular mass, complex structure, biological activity on its structural integrity dependence, complex production process and so on, but unfortunately the existing analysis methods are not enough to understand the full characteristics of such productschemical generics are drugs that have the same active ingredients, dosage form, route of administration and therapeutic effects as reference drugsbiosimilars are not called generics because of the natural variability and complex production processes of biological drugs, resulting in biologically similar drugs and reference drugs can only be similar, but by no means the sameAlthough biosimilars are similar to therapeutic biological products in terms of quality, safety and efficacy, and those used in primary drugsBut the path of biosimilars to validation is filled with uncertainty because it cannot be done 100 percent the same as the original drugwe learnthat that the safety of biosimilars used in push-up indications is also a concern for cliniciansbiosimilars, research and development companies often do "extrapolation" after obtaining approval for an indications - applying all clinical indications corresponding to the original drugclearly, the unproven and unapproved "extrapolation" of biosimilars creates more uncertainty about the clinical efficacy and safety of the drugsay that although biosimilars are relatively small molecular drugs, their compliance is better, but clinicians are concerned about their immunogenicity, because in some rare cases can lead to serious adverse reactions (such as allergic reactions or delayed hypersensitivity), and even endanger the lives of patients , therefore, the safety aspects of biologically similar drugs, including adverse occurrence rates, immunogenicity and extrasoty indications, can not be 100% safely used in clinical practice there is less data on biosimilars, many of the problems are unknown when drug conversion refers to the decision of the prescribing physician to convert one drug to another drug for the same therapeutic purpose for biosimilars, the current clinical practitioners of biosimilar drugs conversion mainly has two aspects, on the one hand, between biosimilar drugs and reference drugs, on the other hand, between the conversion of biosimilar drugs compared to a primary drug, it is usually pharmaceutical manufacturers from thousands of compounds in the middle layer screening, and experienced more than a decade of clinical trials, verification of significant efficacy, before declaring the success of research and development, and then need to go through the clinical trial layer, after several years of verification of safety and effectiveness before being able to get a listing license and the clinical efficacy of biosimilar drugs can not be completely equivalent to the original drug, is derived from the two clinical studies between the end point is different in fact, the original drug used total survival (OS), non-progression survival (PFS) as the end point of clinical research, biosimilar drugs more use objective mitigation rate (ORR) we know that OS is the accepted gold standard for determining the efficacy of cancer drugs throughout medical academia, and ORR is only the end point of substitution the study period with ORR as the main endpoint is short, about 4 or 5 months, which is not enough for the observation of safety events, especially some rare adverse events, which is also a hidden danger for patients it is thus that biosimilars are not the same as those in the original drug at present, China's biosimilar drugs on the market for a short time, doctors and patients do not understand it more comprehensive and more immature, doctors do not know it, many times are based on "non-clinical factors" under the drug due to the lack of clinical experience of the exchange of primary drugs and biosimilar drugs, automatic replacement increases the conversion of biological therapy drugs, which is not conducive to drug traceability, and drug traceability is a necessary condition to ensure patient safety in the drug alert process biosimilars are more accessible to the residents of China by virtue of their similarity in quality, efficacy and safety with reference drugs, as well as price advantages but the original research drug Herceptin has been reduced into health insurance, the cost of treatment for patients greatly reduced, the advantages of biosimilar drugs seem less obvious and the original research drug has been on the market for a long time, regardless of the efficacy and safety is very stable and understood, but the biological similar drug data is less, many problems are still unknown, it seems that there is still a long way to go .