A report carried out by several authors showed that if the launch of biotechnological drugs unleashed controversy at the time due to their novelty, those of biosimilars were even greater. Fifteen years after the launch of the first biosimilar and taking into account current regulations, the question remains as to whether they represent opportunities or risks in terms of safety, effectiveness and costs for patients, physicians and health systems. The challenges are to educate and communicate in a broad and sustained manner about scientific innovation in pharmaco-biology, the value of innovators, and the evidence of effectiveness and safety of biosimilars [1].
According to the authors, the opposition to biosimilars was because there was no clear standard on how to evaluate them and doubts about their safety. This lack of regulation generated confusion and fear, mainly among the medical community. Some organizations and companies argued intellectual property rights and accentuated ‘differences’. However, even innovator biologicals can have small variations over time, due to their origin, development and manufacturing.
According to the World Health Organization, it is very important to improve access to biotherapeutic products and ensuring their quality, safety and efficacy. In 2014, it adopted a resolution recognizing them as biotherapeutic products similar to reference medicines. Biosimilars are developed after patents expire, this substantially reduces costs and improves availability and access to treatment for a greater number of patients.
For the US Food and Drug Administration, a biosimilar is a biological product that is similar to the patent product and has no clinically significant differences from the already approved biological product, provides the same safety and effectiveness benefits as the original, because both are rigorously and exhaustively evaluated.
For the European Medicines Agency, a biosimilar is similar to the ‘reference medicinal product’ already marketed in the EU. Authorized biosimilars can be marketed after the ten-year period of market protection for reference drugs has expired.
In their report, the authors highlighted that the challenge of innovative biologicals is the perception of high cost, understandable because pharmaceutical companies invest a lot of money and time in research and development of each molecule, and the manufacturing process requires sophistication and cutting-edge technology. The result: effective, fast-acting and tolerable drugs in the treatment of immune diseases, cancer, diabetes, multiple sclerosis and rare diseases, among others, and the significant recovery of patients' health.
The report concluded that innovative biologicals represent significant advances; biosimilars are the option for more and more patients to have access to biotherapies in the fight against immunological, oncological and chronic degenerative diseases.
Conflict of interest
The authors of the report [1] declared that they are employees of Llorente y Cuenca, Mexico/USA.
Abstracted by Javier Marín, Americas Healthcare Practice Leader, Llorente y Cuenca, Mexico.
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Reference
1. Romero A, Marín J, Rosell G. Biológicos y biosimilares: un matrimonio de conveniencia que beneficia a la sociedad. Ideas LLYC. 2021 Aug 4.
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