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Biosimilar drugs must follow the same genetic sequence as the reference biological products. Photo: PhotoLizM / Pixabay
Anyone who visits the pharmacy with a certain frequency has already noticed that there are reference drugs, generics and the like. In the end, the main difference between them lies in the price, and this also applies to biologics, whose treatment can cost up to $ 10,000 per month.
Produced from living organisms, cells or bacteria, Biologic drugs are used to treat more complex diseases, such as cancer. In addition, they are more effective than synthetics and reduce potential side effects. Some vaccines, like yellow fever, for example, are organic because they are produced using the attenuated virus of the disease.
"Biosimilars are also organic, but they were not innovators, are produced by one cell, follow the entire production process, but do not have any preclinical studies, as if they are it was an invention ", explains the pharmaceutical company Márcia Bueno, director of institutional relations of Libbs.
The company inaugurated Biotec in Brazil in 2016, an industry that produces six biosimilar drugs. Among these is the compound trastuzumab, which has been approved simultaneously by the National Health Surveillance Agency (Anvisa) and by the FDA (US Regulatory Agency). It is indicated for the treatment of early and advanced bad cancer, in addition to metastatic gastric cancer.
"The importance of biologics lies in the fact that, with advances in biotechnology, it is possible to determine which tumor to use to prevent cell growth [cancerígenas]." diseases will be increasingly treated with these drugs, "says the expert.
In addition, the existence of biosimilar acts in the monopoly of companies producing the reference drugs. price, biosimilars can be advantageous for inserting them into the public health system.According to the Ministry of Health, biologics currently account for 51% of the R $ 3 billion spent annually on the purchase of drugs – and only 4% of the amount of drugs dispensed by the Unified Health System (USS) [19659009] Element of biosimilar drug production process at Biotec. ” clbad=”img-responsive”/>
Element biosimilar drug production process in Biotec. E + is maintained with Márcia Bueno to understand what are the biological and biological remedies for the disease, the biosimilars and the differences between them. Check below:
What are the biological and biosimilar remedies and what is their difference?
In biological, the source of production is biological. They are usually produced by cells or bacteria. Among biological drugs, there are monoclonal antibodies – proteins that will react in the body with a specific receptor. The biosimilars are organic, but they were not innovative but use the reference medicine [como base]. They are also produced by a cell, follow the whole production process, but do not have all the preclinical studies as if it was an invention, they were already starting from a ready molecule.
The biosimilar is exactly the same as the biological reference. can there be changes?
To produce a biosimilar, you must follow the same genetic sequence as the innovative remedy. As a result, a process is developed in which the selected cell has a high production of the protein that will make the drug. The process is not exactly the same because it changes the conditions but follows the same characteristics as a culture medium for the growth of cells and proteins.
What makes biological remedies more effective, the use of living cells?
Yes, that's what we are looking for: to be effective and reduce side effects. If the drug is self-directed, it will only react with the tumor cell and reduce the impact on others. When they do not self-target, they have significant side effects. The incessant quest is to have a therapy that has the lowest dose with the desired effectiveness. The comparison is with chemotherapy: it is effective, but it reaches several other cells, it is not autonomous, so that the woman loses her hair, she has nausea. What we are looking for are new drugs to reduce this phenomenon.
Organic products are expensive drugs. Are biosimilars too?
Biosimilars are new in Brazil and around the world. Biologic drugs are expensive because they invest a lot in research. Keeping the new product alone for a long time is a monopoly and the price does not drop. In addition, biosimilar improves competitiveness. At first, biosimilar will not have any price reduction, because we must still consider the investments in facilities and development, which are high, but the fact that there already exists is beginning to reverse the price of the reference medicine. A study by the World Health Organization showed that the price of organic products on the list with potential for new biosimilars had already been reduced by 50% compared to those who had not yet competed . As the patent falls, the price goes down.
What is the potential for expansion of biosimilars in the public system? It depends on the disease?
Inclusion in the unified health system list, when it is a reference drug, already has it in most cases. Depending on the disease, the purchase is concentrated in the Ministry of Health or secretaries [estaduais ou municipais de saúde]. Can biosimilars have a longer and more complex registration process than other remedies?
When preparing a complete biosimilar, the development time is much greater than other synthetic remedies, as well as the new biological [de referência]. Once you have entered a file and requested your registration to Anvisa, the time of badysis is the same. Anvisa has one year to answer. In Brazil, we have a clear distortion compared to other countries. Here, the patent is counted in the concession, the queue is too long, we can stay online for up to ten years. In other countries, the patent already counts as a queue.
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