What are the advantages of the original research drug?

On the one hand, many original research drugs such as quercetzumab in the safety and effectiveness of the advantages, the renewal of medical insurance and then reduce prices, played a cost-effective advantage.
on the other hand, with the expiration of patent of primary biological drug and the continuous development of biotechnology, the safety monitoring of biosimilar drug market is becoming more and more important.
biosimilar drugs, can not replicate the original research drug recently "anti-tumor biosimilar drug drug monitoring drug monitoring drug expert consensus" issued, put forward the clinical treatment of biologicalsimilar drugs therapeutic drug monitoring (TDM) need, individual monitoring program points, technical methods and clinical pharmacist participation links.
biosimilars are therapeutic biological products that are similar in quality, safety and efficacy to approved reference drugs.
the publication of this Consensus is also based on the fact that biologically similar drugs, although similar to those of the original drug, are similar to those of the original research drug in terms of quality, safety and efficacy, but cannot be 100 percent the same as the original research drug.
, unlike chemical lysis, the safety and efficacy of biosimilars still have a long way to go.
the first face is that because biosimilardrugs can not accurately replicate the original drug, there is inevitably an immune progenitor difference between the two, and may lead to unexpected immune response.
and the immunogenicity of the original drug has been verified by a large number of clinical studies, has been fully evaluated and managed, usually caused by a small immune response or will not cause an immune response. At the same time,
, the original research drug and biological-similar drug interchange have a certain safety risk.
for example, heceptin, which benefits more than 3 million HER2-positive breast cancer patients worldwide, has undergone 22 years of real-world treatment, follow-up time of more than 10 years, safety and tolerance have been fully verified, and the clinically recommended treatment optionist is heceptin (qutozhuzumab) and Pasett (Pactozhu monotag) dual target treatment plan has been approved by more than 80 countries, including the United States and the entire European Union.
and related biological-similar drugs, not only do not have real-world treatment experience as the basis, there is no related research with patozumab combination therapy, clinical efficacy is not known.
in addition, from a market perspective, the incidence of malignant tumors in China has maintained an annual growth rate of about 3.9% over the past 10 years, Frost and Sullivan, Guangfa Securities Development Research Center forecast that China's biosimilar drug market sales revenue is expected to grow from 1.6 billion yuan in 2018 to 25.9 billion yuan in 2023, CAGR 74.2%, and is expected to grow by 12.5% CAGR, in 2030million.
, whether it is the release of the "Consensus of Experts on Drug Monitoring of Anti-Tumor Biosimilar Drugs" or the discussion of biosimilar drug safety regulation at the industry summit, or the fact that the expansion of the market further requires drugs to ensure quality and safety and effectiveness, it can be seen that the industry is paying more and more attention to the safety monitoring of biosimilar drugs.
actively recommended to promote the safety monitoring of biosimilar drugs a former research drug company said that, as the highest priority for patient safety and interests of the pharmaceutical company, in accepting and respecting the regulatory authorities' approval decision on biosimilar drugs, adhere to the prescription doctor based on full and objective data to make drug choices, while recommending access decisions can fully consider the overall clinical evidence and other factors, and not limited to price dimensions, advocate that patients have full access to their therapeutic drugs and the right to know.
in addition, there are already many at home and abroad in the constant search for solutions and suggestions.
clinical swaps, the European Society of Oncology (ESMO) recommendations for prescriptions for oncologists mentions that the means used by chemical generics should be avoided in the field of biosimilars, only if the doctor knows the product well, the doctor fully clarifies the situation to the patient, the nurse closely monitors the changes in treatment and tracks adverse events.
from the domestic enterprises of the single anti-drug market pharmaceutical evaluation, CDE also published related concerns, thinking and suggestions, in the "on China's single anti-drug market stage of pharmaceutical evaluation" article pointed out that the quality of the production of drugs and the regulatory authority of the product after the market needs to be strengthened.
in this case, how can the domestic drug review agencies learn from the experience of developed countries in Europe and the United States in the regulation of listed drugs... The original research drug, the peace of mind choice "new anti-tumor drug clinical application guidelines (2019 edition)" mentioned that in the clinical application of anti-tumor drugs, should fully consider the price ratio of anti-tumor drugs, the preferential choice of drug economics evaluation and high price ratio of drugs.
in the case of biologicalsimilar drug safety monitoring is constantly being taken seriously, some of the original research and pharmaceutical companies also uphold the principle of patient safety and interest sane priority, and constantly seek benefits for patients, such as the first time after entering health insurance fell by about 69%, 2019 after the success of the national health insurance renewal to reduce the 24% of the qural supret, in the continuous reduction of the financial burden of patients.
the safety and efficacy of the original drug is the result of long-term clinical trials, for patients, in the treatment choice to consider the price issue, but now, as the price of the original drug, the low-cost advantage of biological-like drugs will also be squeezed.
, therefore, in line with the treatment standards, safety monitoring qualified biosimilar drugs before the market, the price of preferential, high-quality primary research drugs, is also a good choice.
Reference Materials: "Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial)" "Modern Drugs and Clinical" "Reflections on Pharmaceutical Evaluation in the Market stage of China's Monoantidrugs" original title: The Original Research Drug, Advantage Trio.