Professor Liu Jian: China's biosimilardrugs meet international standards to meet the affordable drug needs of breast cancer patients

Breast canceris the highest incidence of malignant tumors in women, the 5-year survival rate of about 70% to 90%, is also the number one cause of cancer death in womenHER2-positive breast cancer accounts for about 25% of all breast cancer patients and is one of the main subtypes of breast cancerAt present, although anti-HER2 treatment can significantly improve the prognosis of this part of patients, but due to drug accessibility factors, there are still some patients can not obtain anti-HER2 treatment, and with the strong rise of Chinese biosimilar drugs, the future anti-HER2 treatment of cancer drugs will be greatly improvedthe importance of anti-HER2 treatment
breast cancer into the era of targeted treatmentIn 2011, breast cancer began to be molecularly classified, of which HER2-positive breast cancer accounted for about 25% of the total, is a very large group of breast cancerToday, breast cancer treatment has entered theprecisionmedical treatment, HER2 is both the driving gene of breast cancer and anti-HER2 target, therefore, anti-HER2 treatment is the most important treatment of HER2-positive breast cancerAt home and abroad major guidelines recommend anti-HER2 drugs for HER2-positive breast cancer standard treatment drugsthe development of biologically similar drugs such as chinese-made qural-bead monoytobarbita
the research and development of new biological products, is a hot topic in the world, and the key to its research and development is to obtain data on the safety and effectiveness of human tests, biosimilar drugs to compare head-to-head with reference drugs, to achieve a comprehensive similarity And complete evidence, including analytical scientific characteristics (physical and chemical properties, biological activity, purity and impurities,immuno
properties, quality indicators, stability, etc.), non-clinical trials and clinical trials, and even comparison of host cells, preparation prescriptions, specifications and internal packaging materialsthe development ofbiosimilars based on the principle of progressive progression, relying on comprehensive "comparison studies" to establish the similarity of candidate drugs and reference drugs, and the need for a comprehensive head-to-head comparison study between candidate drugs and reference drugs, including analytical, non-clinical and clinical comparison studiesUnlike the development focus of bio-innovative drugs, in the development of biosimilar drugs, pharmacological analysis of similarity is the key to the development of success, for biosimilars, pharmaceutical-to-drug and non-clinical comparison studies prior to the conduct of clinical trials have been able to fully explain their similarity with the original drug, clinical trials are intended to further eliminate any uncertainty about similarity, to prove the safety and efficacy of the two equivalentsThe whole process is very comprehensive and strict, only under the premise that the similarity of each step is established, can be approved with biosimilar drugsthe design of clinical trials of domestic querceon mitadrug biologically similar drugs
clinical matching studies usually start from pharmacokinetics and/or pharmacodynamic sorscores, and consider the follow-up clinical efficacy ratio trial based on its similarity evaluation resultsResearch design should be designed with the aim of proving the similarity between the candidate drug and the original research drug, carry out scientific and reasonable research design, and simplify the research as far as possible and reduce the cost on the premise that there is a reasonable scientific basisAt present, the clinical research and development of curtlyzumab biosimilars at home and abroad is more than a pharmacokinetic ratio study and a clinical safety effectiveness comparison studyfor clinical effectiveness and safety ratio of the study population to choose HER2-positive MBC first-line treatment patients and HER2-positive EBC new auxiliary patients are selectable research population, pCR and ORR are HER2-positive early breast cancer new auxiliary treatment and metastatic breast cancer first-line treatment of sensitive efficacy endpoint index, can be used as the main endpoint of the clinical effectiveness of qural supret supret biosimilar drugsIn terms of boundary value selection, the equivalent boundary value can be estimated based on the lower limit of the confidence interval of the reference drug treatment effect, while the reference drug treatment effect is the efficacy ratio/difference of reference drug group and control groupthe international standard of domestic quercetal mitabolate biosimilarsthe European Union is the world's first to develop guidelines for biosimilars, so Europe is also the world's leading arena for biosimilardrugs, the world's top biosimilar drug companies are competing in the same arenaThe European DrugAdministration (EMA) has very strict regulatory rules for the listing of biosimilars Biosimilars in China started relatively late, but have made rapid progress in recent years Fu Honghanxuan's HLX02 is the first biosimilar drug developed in China, and the European Union and China are simultaneously declared listed as biosimilar stakes, which is exemplary and significant in the development of biosimilar drugs in China Fu Honghanxuan began to develop biosimilar drugs in accordance with EU standards before the technical standards for biosimilar drugs were introduced in China HLX02, which has received positive review opinions in the European Union, is a high lying recognition of "Made in China" biosimilars by the international authority At the same time, high-quality biosimilars also give clinicians and patients more confidence in treatment options In clinical decision-making, the efficacy, safety and affordability of the drug are all important factors It is precisely because of the high standards of HLX02 biological similar drugs in the development of Fuhong Hanxuan, high quality at the time of production, so that doctors have more confidence, so that patients more assured of treatment Source: Cancer Information