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Two Breast Cancer Endocrine Therapy Drugs have Passed the Consistency Evaluation

2021-09-10
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Breast cancer is a hormone-dependent tumor. Studies have found that for breast cancer patients who are hormone receptor-positive and cannot tolerate surgical treatment, endocrine therapy has found better results. The two commonly used breast cancer endocrine therapy drugs, tamoxifen citrate tablets and anastrozole tablets, have both passed the consistency evaluation of the quality and efficacy of generic drug research and development. This will reduce the safety of the people’s medication and improve The effectiveness of drugs and the improvement of the overall level of China’s generic drug research and development have improved the guarantee.

Experts have shown that the growth and apoptosis levels of breast cancer tissues are positively correlated with the continuous increase in endogenous estrogen levels and exogenous supplementation of estrogen. Therefore, they believe that the increase in estrogen levels increases the prevalence of breast cancer. Breast cancer is a hormone-dependent tumor. The mechanism of endocrine therapy for hormone-receptor-positive breast cancer is to change the endocrine microenvironment required for the growth of hormone-dependent tumors, so that the proliferation of cancer cells stops at the G0/G1 stage, and then reaches The purpose of tumor prevention and control. The purpose of endocrine therapy includes two aspects, one is to reduce the level of estrogen, so that the tumor is not stimulated by estrogen, and the other is to inhibit the synthesis of estrogen. For advanced breast cancer, endocrine therapy has become an important treatment. The traditional first, second, and third-line drugs for endocrine therapy are tamoxifen (TAM), progesterone, and aromatase inhibitors.

The main component of tamoxifen citrate tablets is tamoxifen citrate, which is a non-steroidal anti-estrogen drug. Its structure is similar to estrogen. There are two isomers of type 2 and type E. Type E has an anti-estrogen effect. Type Z can competitively bind to estrogen receptors to form receptor complexes to prevent estrogen from destroying the breast. It is mainly used for the treatment of female recurrent and metastatic breast cancer and breast cancer surgery Adjuvant treatment of post-metastasis to prevent recurrence. Tamoxifen citrate has passed the quality, efficacy and consistency evaluation of generic drug research and development, which will be able to reduce the drug burden of the people, reduce medical insurance expenditures and enhance the efficiency of the use of medical insurance funds. The quality and efficacy consistency evaluation of generic drugs is Yangzijiang Pharmaceutical Group’s tamoxifen citrate tablets. In addition, the endocrine therapy drug Anastrozole for the treatment of breast cancer by Yangzijiang Medicine has also passed the consistency evaluation.

The purpose of the consistency evaluation of the quality and efficacy of generic drugs is to control the quality of drugs from the source through the evaluation of the quality and efficacy of generic drugs, improve the quality of the generic drugs that have been marketed, and eliminate varieties whose internal quality and clinical efficacy do not meet the requirements. In terms of quality consistency evaluation of generic drugs, Medicilon has successfully completed a number of quality consistency evaluation cases. It has rich experience in the research and development of generic drugs and can provide customers with more professional consistency evaluation services.

Anastrozole is a potent and selective non-steroidal aromatase inhibitor, which can effectively and selectively inhibit the activity of aromatase, effectively reduce the blood E2 level, thereby inhibiting the growth of tumors, and can be used for the treatment of postmenopausal Advanced breast cancer. In the early years, there were reports in the literature that aromatase inhibitors represented by anastrozole have gradually become the gold standard for adjuvant endocrine therapy in postmenopausal estrogen receptor-positive breast cancer patients. Aromatase inhibitors (Aromataseinhibitors, AI) inhibit the activity of aromatase and block the conversion of androstenedione and testosterone from tissues other than the ovaries into estrogen through aromatization, so as to inhibit the growth of breast cancer cells and treat tumors. AIs apply to postmenopausal.

The consistency evaluation of generic drugs has played a positive role in the development and production of generic drugs, as well as allowing patients to use high-quality and low-cost drugs. As we all know, the original research drug has a long research and development cycle, large investment, and high price. Therefore, economical, effective and more accessible generic drugs are widely encouraged internationally. Generic drugs have the same active ingredients, dosage forms, routes of administration, and therapeutic effects as the original drugs. They have important economic and social benefits such as reducing medical expenditures and improving the availability of drugs. They are also an important guarantee for realizing “being treated for diseases”.

Experts pointed out that by promoting the consistency evaluation of generic drugs and gradually expanding the scale of the generic drug market, creating a good development environment for generic drugs and allowing them to more fully compete with innovative drugs can drive the price of innovative drugs back to the level of generic drugs. A feasible way to reduce drug prices.

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