Biotechnology in the health care sector and biosimilars
Biotechnology, by definition, is the use of technology in biological processes. It is present in our lives in different aspects, whether in the agriculture and livestock industry, or in the environmental and industrial sectors. Biotechnology has also generated a breakthrough in the healthcare world.
Genetic and regenerative therapies, xenotransplantation, personalized medicine, among other things, can be achieved thanks to biotechnology. The specialized field has decided to call the use of bio-organisms in medicine “red biotechnology”. It provides data for the creation of antibiotics, drugs, and vaccines. Thanks to the efforts of biotechnologies, vaccines against Coronavirus came out in record time. At the same time, it is a great help for personalized medicine in terms of knowledge of the patient’s genetic profile, which opens up the possibility of personalized medicine that improves precision in diagnoses and in making decisions on prevention or treatment for a given disease. The Spanish Society of Oncological Medicine believes that biotechnology in the medical sector is a “revolution in the treatment of cancer patients” due to the therapeutic advances it is providing. The Biotechnology Journal has published an article which demonstrates that “Microwell-based flow culture increases viability and restores drug response in prostate cancer spheroids”.
In addition to the advances in biotechnology, there are also biosimilars. A biosimilar is defined as a biological drug which is equal in efficacy, quality and safety to an original drug. Its approval is based on scientific-medical evidence, in which the regulatory authorities apply the same criteria as for the original biologics. Approval will depend on the result of the “comparability exercise” -which ranges from 6 to 12 years of study and aims to accredit with sufficient guarantees that both products share the same efficacy and safety-.
In Spain and in other countries belonging to the European Economic Area, the authorization of this type of drugs is determined by a centralized procedure. The European Medicines Agency is responsible for evaluating the dossier of the candidates. Thanks to biotechnology and biosimilars, a healthier future lies ahead for the population. Medicine and biotechnology will work together to advance the quality of diagnosis and treatment.
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