Biotechnological medicines are manufactured with assistance from live beings or technological metabolic processes, in a manner, which for instance, a bacteria produces hormones such as insulin or immunoglobulin. They are used mainly for the treatment of several types of cancer and rheumatoid arthritis and have been developed for almost 20 years. Therefore this is why the question is raised: Why is this matter being discussed now? When they were introduced into the market, weren´t there issues with safety and effectiveness?
The response is clear, these products will compete with medicines currently in the market and the consequence is a reduction in price, and also consequently decreasing large pharmaceutical company shareholder earnings.
From the introduction in the market, biotechnological medicines have produced grave reactions due to the impact to the immunological system, favoring the development of diseases such as tuberculosis, also increasing the risk of cancer and brain reactions such as progressive multifocal leukoencephalopathy, among others.
Furthermore, most of them currently used for cancer treatment, except for a few exceptions, do not increase life expectancy in more than a year, in other words, they do not cure the disease, and as other medicines, do not work the same on every patient or are not as efficient in some patients, as published in the Navarra Pharmacological Information Bulletin (August-October 2011).
In the case of rheumatoid arthritis, there are already studies form the Institute of Technology Assessment in Health of 2013 which demonstrate that biotechnological medicines are not superior to actual therapy with modifiers which delay the progression of the disease.
Saying, like some publicity has stated, that the requirements for entry of new competitors (biosimilar medicines) into the market will be lowered shows great ignorance, as the quality conditions required by the National Food and Drug Oversight Institute (INVIMA, for its Spanish acronym) are the same of the US Food and Drug Administration and the European Medicines Agency.
Production is not complicated either. Those who say speak about the complexity, need to be reminded that the DNA structure, a much more complex molecule, was discovered in 1953, almost 65 years ago. In that time, there were no computers or other technologies which would facilitate the work of researchers Watson and Crick.
For this reason, these processes are perfectly standardized and it is possible to produce biosimilars, inclusively in standard laboratories and accessible to any researcher, as those of the Universidad Nacional de Colombia (UNal) Biotechnology Institute.
There are specialized professionals, state-of-the-art technologies, immediate access to sources of information which greatly facilitate not only the design but the optimization of its manufacturing processes. This may be easily seen in the quick progress of computers, such as the ENIAC computer which occupied several floors and weighed 27 tons and could perform 5,000 sums and 300 multiplications per second, up to the current smartphones, real pocket supercomputers.
There is no such complexity and today biosimilars may be produced in any laboratory, in other words, biotechnological medicines with an expired patent. Therefore, they may be freely manufactured, produced and compete with biotechnological medicines, which currently have valid patents. This is not so good for multinational pharmaceutical companies because they have to reduce the price of their drugs, but on the contrary, good for any health system, like the Colombian healthcare system. Being less expensive, these systems may be more sustainable.
The issue is a consequence of the Free Trade Agreement signed with the United States of America and in effect since 2012, as before medicines entered the country without any strain. Who may be the competitors? Countries such as India and China which produce biosimilar medicines which will result more economical. There are not any quality issues because the medicines are not consumption but social products, destined to save lives.
Finally, the term biolimbos, used in the advertisement against biological medicines does not exist in the Colombian legislation according to official information from INVIMA. Therefore its use has a pejorative character in response to the lack of success of publicity campaigns where they have not been able to discredit the work of the Colombian Ministry of Health with the biosimilar issue.
* CIMUN: Medicine Information Center (CIMUN, for its Spanish acronym) is an independent and up to date, objective and opportune service on medicines and their use.
Consejo Editorial: Fredy Chaparro Sanabria Director Unimedios, Nelly Mendivelso Rodríguez Oficina de Prensa, Liseth Sayago Cortes Oficina de Realización Audiovisual, Carlos Raigoso Camelo, Oficina de Producción Radiofónica, Ramiro Chacón Martinez Oficina de Proyectos Estratégicos.
Editor: Álvaro Enrique Duque Soto
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