“I personally believe that if correctly formulated standards are strictly applied so that a drug can replace a patent medicine and retain its original bioequivalence and bioavailability properties, it will be an absolute success in controlling the disease and preventing complications. The best choice. Dr. Raúl Ramírez León, former director of the General Hospital of Balbuena, exclusively said:
“It is known that when a patent expires, any laboratory can produce the drug, thereby creating a generic version. Generic drugs can be used, sometimes as a substitute for the patented drug or the original or innovative drug (at its inception).
“Assuming that they have supported and approved a series of interchangeability, bioequivalence and bioavailability tests that demonstrate that their conduct under the patent is equivalent in terms of duration of action, potency, efficacy and safety, this They are guaranteed to contain the same active substances, purity, particle size and effect as the original brand products,” explains Raúl Ramírez, specialist in intensive care medicine.
Conceptually, the literature review:
An innovative or patented product is a drug resulting from a research process, protected by a patent, and produced exclusively by the pharmaceutical laboratory that developed the product. They are named after the name of the active substance and the name or trademark.
Interchangeable generic drugs: refers to drugs that have the same drugs or active substances, routes of administration, concentration or potency as the innovative drugs, and are proven to be identical or equivalent to the innovative drugs through interchangeability tests. It is named after the active substance. Should always be specified with capital letters GI.
Interchangeability testing refers to the testing that must be done to approve interchangeable generics to demonstrate that they perform the same in the body as the innovator. To demonstrate this behavior, a drug must comply with different types of tests, depending on the properties of the drug, such as dissolution and bioequivalence or bioavailability.
Similar drugs and interchangeable generic drugs are not the same. Only interchangeable generic drugs have been tested to prove that they are interchangeable with the innovator drug, which means that they will behave in the same way in the human body as the patented drug.
“Personal experience. Most of the medicines used by the health sector are similar, non-interchangeable generics, which do comply with all established regulations. Therefore, the use of similar medicines does not achieve the desired therapeutic effect, which has long-term consequences for the health sector Raúl Ramírez, a specialist in critical care medicine, said the health of patients is already at risk, especially those with chronic degenerative diseases that develop late complications more quickly.
“Therefore, to compensate for chronic conditions with similar drugs, higher doses, combinations, favoring polypharmacy are needed, which further complicates cardiometabolic control in older patients, favoring drug-induced gastritis, etc. Gastrointestinal disorders.”
“The same situation occurs in patients with musculoskeletal disorders and receiving analgesic and anti-inflammatory drugs to control pain, in whom the dose must be increased, producing gastric symptoms in the best cases and gastric symptoms in more severe cases In cases where the kidneys can be damaged. Complications, to give two examples.”
“It is important that people are aware of this type of information because, unfortunately, most patients will go to a pharmacy to self-medicate and/or take advice from dispensers who have no pharmacology experience.”
“Currently, there are many commercial brands and unknown laboratories supporting the active substance as generics, but in reality it is unknown whether they have been biosafety tested to guarantee the same active substance and therefore the same effect as the original product”, Physician Lau Raúl Ramírez emphasizes.
frame. I would like to thank the National Engineering Association Unit (UNAI), the architects Eduardo Sánchez Anaya and Lic. Guillermo Jiménez Morales for recognizing my column “Science Frontiers” and for their recognition of the communication of science and technology.
National Journalism Award in 2008 and 2016. Mexico Journalism Awards 2023. ferfuentesmty@hotmail.com