The clinical trials are mandatory otherwise the drug will not be registered. And this process is undertaking, long-lasting and cost – ineffective. Properties of selected molecules are examined chemically, in cell and animals cultures (stage of laboratory and preclinical) determining potential effectiveness and toxicity. Based on these results it is applied for clinical trials in the regulatory authorities, which are conducted after obtaining permission. These tests are carried out in three phases.
During the first phase potential drug is tested on several dozen of healthy volunteers determining the safety profile gradually increasing doses, pharmacokinetics (i.e., how drug is absorbed into blood flow, is distributed to various tissues, metabolized and excreted from body) and pharmacodynamics (i.e., how drug performs on a predetermined target, what effect it produces).
Several hundred patients were participating in the second phase. Its main objective is to determine substance effectiveness at the ongoing monitoring of side effects. As a rule, the second phase is divided into stage II-A, in which the required dose of medicine is selected, and phase II – B, which studies drug effects at a given dose.
Trials during the third phase, as a rule, are multicenter (performed in several hospitals, preferably geographically remote) controlled (drug compared to placebo), double-blind (neither the patient nor the physician does not know the assigned drug or placebo) randomized (distribution members between experimental and the control group was randomized) studies involving thousands of patients. In this phase, the potential benefits of clinical substance uses and incidence of various side effects are estimated. Based on its results is permission to sell the drug given. Following the drug release on the market, the study continues in post-marketing studies.
The whole process of developing a new drug takes on the average of more than 10 years and, in the case of drug release on the markets all over the world, worth hundreds of million dollars. Therefore, original products protected by the patent are very expensive.
When the patent term on the original product expires, the right to make a copy of it has any pharmaceutical company. These copies are called generic and because the manufacturer does not have to invest in the development and testing of the molecule, they are much cheaper than the original drugs. Prices reduction promotes competition between producers. Because of the relatively low cost, generic drugs make 80 percent of all medicines consumed in volume. For example, data on FDA in the United States show that generic drugs are recommended in 8 out of 10 prescriptions.
There is no difference if they are produced and tested properly. Generics must contain the same active ingredient at the same dosage as the original drug, administered by the same way (oral, intravenous, etc.) and have the identical quality indicators, and similar safety and pharmacokinetic properties based on the bioequivalence study results (if applicable). The molecule of “classical” drugs must exactly reproduce the original (due to the small size of the molecule to make it relatively easy). The release form may be different (e.g., capsules instead of tablets), the coincidence of inactive ingredients is not required provided that such alterations do not affect the key characteristics of bioequivalence.
The quality of generics is confirmed in the so-called bioequivalence studies (usually involving several dozen patients), during which the identity of generic parameters of pharmacokinetics with the original drug is verified. The main objective of these studies – show that drug enters the body and is absorbed in the same manner as the original drug. If the substance is identical to the original molecule on the basis of physical, chemical and preclinical research, it enters the body the same way, there are no prerequisites for the differences in drug action.
For some generics (eg, an intravenous form of administration) according to international standards can be registered without bioequivalence study, as this route of administration has the same preparations’ composition falling directly into the blood, that is, absorption question for them is irrelevant. Time spent on active substance development and a multi-phase clinical research is not required, generic drugs are brought to market much faster and present for a large number of patients low-cost treatment.
This operation is absolutely legal. Patents on drugs differ from other protection technologies – there is a question of human health and pharmaceutical benefits must be affordable. Therefore, the patent term is limited. It is different in various countries, but in most cases, this period lasts for 20 years. In the United States and the European Union, as well as in the majority of other countries, the patent may be extended for more five years. While the patent is valid, the producers in competition absence, sell the original drug at a high price in order to compensate its development expenses and make a profit.
Of course, pharmaceutical companies invest billions of dollars in new medicines development being unhappy period patents limitation. They use a variety of tricks to extend the protection of their intellectual properties – from obtaining a new patent, slightly changing drug composition (for example, register different sulfate), to purchase a potential generic producer. In English literature the totality of tricks called evergreening (literally a “maintenance in the evergreen state”). But even when these tricks are activated, they can only delay generic drugs production start but does not prevent it.
Canadian Health&Care Mall specializes in generic drugs because they are affordable and high-quality.