Table/Compare the differences between biological agents and chemical drugs? Authorized by the Taiwan Province Cancer Foundation, the emergence of biological preparations of what are biologically similar drugs has really changed the treatment methods of many diseases in the past two or three decades, significantly prolonging the survival time of patients and improving the symptoms of diseases. However, with the expiration of the patent protection period of biological agents in various countries, biologically similar drugs have gradually appeared in the market. Biomimetic drugs are not generic drugs. We often hear that generic drugs only produce the same chemical structure through chemical synthesis, and the process is relatively simple. On the contrary, biologically similar drugs are produced by genetic engineering in living cell lines, so the differences in molecular weight, complexity and technology are covered, and the research and development procedures are far more complicated than generic drugs.
Why do you need biologically similar drugs? The global sales of biological agents whose patents will expire in 2020 are as high as $67 billion. Therefore, the business opportunities of free competition in the market have promoted the vigorous development of biologically similar drugs in recent years, and the appearance of biologically similar drugs will certainly help to improve patients' chances of receiving biological agents. In addition, for * * * health departments and medical insurance units, in the case of limited medical resources, it is also happy to see biologically similar drugs listed to save drug costs. Based on the medical regulations and standards and the experience of biological preparation manufacturing, the cost of new drug research and development is saved by simplifying clinical trials and expanding indications, so the price of biologically similar drugs is fed back. These saved medicine fees can be paid to other innovative new drugs and medical care technologies to take care of more patients.
The production and strict quality control of biologically similar drugs are the key. The process information of most reference drugs belongs to patents and is not disclosed to the public. Therefore, manufacturers of biologically similar drugs must develop new cell lines and customize their own processes. Compared with generic drugs, the development of biosimilars is more accurate and complicated. There are about 250 process quality tests in the production of biosimilars, but only about 50 are needed compared with small molecular generics. In the manufacturing process of biologically similar drugs, firstly, many batches of reference drugs are analyzed to establish the benchmark, and then the living cells go through complex and elaborate multi-step procedures, and through tens of thousands of experimental data analysis, physiological function evaluation and final clinical trial direct comparison, the similarity between biologically similar drugs and reference drugs can be ensured. Biomimetic drugs are highly similar to biological agents currently approved for marketing, and also have more complex regulatory review standards, which are used to control and maintain drug quality and strictly control patient care.
How to find the best cell line and produce biologically similar drugs with the same effect as the reference drugs is the key, and these steps need trial and error. In addition, the control of parameters and quality in the production environment also determines whether each batch of drugs can maintain the same effect.
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