Scientific research and innovation have made it possible to develop various more effective solutions against multiple diseases. The notable and greatest benefit is that patients now have a higher quality and life expectancy. The challenge now is to make these innovations accessible to as many people as possible. And precisely one of the advances achieved can be seen with biocomparable drugs.
Differences with generics
In this regard, Dr. Daniel Freire, Regional Medical Director of Sandoz points out that they are biologics with a high degree of equivalence in terms of quality, efficacy and safety with respect to their original or reference medicine but whose patent has expired. Despite being a drug with equivalent characteristics, a biocomparable cannot be considered a generic of the reference medicine because its biological nature will never be an identical replica.
Currently, there are biocomparable drugs available to treat various diseases of high prevalence in the Mexican population. Some of the main ones are diabetes, rheumatoid arthritis, hematological and oncological diseases, anemia associated with chronic kidney failure, dermatological diseases and fertility treatments, among others.
How are biocomparables approved?
For her part, Dr. Katia Pineda, Medical Director of Sandoz México, pointed out that in order to approve a biocomparable, it must be demonstrated through highly sensitive physicochemical and biological activity tests (comparability exercise) that there are no significant differences with respect to the reference biological. By this he refers to: quality, efficacy and safety, thereby providing the same clinical benefits.
He added that the commercialization of biocomparables encourages competition in the pharmaceutical industry, especially among producers of reference biologicals that are protected by patents. That is why we constantly seek to develop new innovative drugs, thereby promoting scientific and medical development. In addition, the production of biocomparables boosts patient access to biological medicines and contributes to the economic sustainability of health systems.
“Chemical drugs are very small molecules with simple structures, defined characteristics and perfectly reproducible. On the other hand, innovative biological drugs are more complex because they are composed of larger molecules from natural proteins, obtained from living organisms such as bacteria, yeast or mammalian cells ”.
These biologics represent the cutting edge of biomedical research because they offer more effective means of treating untreated diseases and infections.
Biocomparable medicines are generally expected to be offered at a price of 15 to 30 percent lower compared to the reference biological product. The reason is because manufacturers must invest in clinical trials, manufacturing and safety monitoring programs, after the approval of their biocomparable, in the same way that manufacturers of innovative biologics do.