When a company develops a new drug with a therapeutic activity, this company must give this drug a brand name (or protected trademark) as well as a generic name. The generic name does not have an owner. It is known as INN (International Non-Proprietary Name).
If after a series of studies and testing this drug is approved by the appropriate National Health Authority, the pharmaceutical registration is obtained. The pharmaceutical registration is the authorization issued by the appropriate National Health Authority in each country to commercialize it as a pharmaceutical product with a specific indication.
In countries where the State provides intellectual property protection these products may have some kind of patent or data protection, so that for a time the original product has a monopoly market.
Nevertheless, for a laboratory to be able to commercialize a generic product as a pharmaceutical product, it has to register it. This means to obtain the commercialization authorization from the appropriate National Health Authority.
A generic product is interchangeable with the original product because it has the same active ingredient, the same route of administration, the same pharmaceutical form and behavior as the original drug. In other words, it is identical with the original drug in terms of safety and efficacy, it behaves exactly the same, and has the same indication. Like the original drug, it must meet the same quality and control standards during the manufacturing process.
The State acting through the appropriate National Health Authority is responsible for determining its final approval before the product is authorized to be sold on the market.
The existence of generic products on the market encourages competition, causing a price reduction of pharmaceutical products on the market, and consequently granting the population as a whole access to a product.
Furthermore, the generic product exercises a control power on monopolic situations, in this way innovative laboratories are motivated to research even further. If innovative laboratories kept their exclusive rights forever, they would not need to make efforts in Research and Development to stay on the market.
Likewise, a generic product boom allows for the development of small companies, which may eventually develop their own Research and Development structures.
As we said, a generic product is one that contains the same active ingredient, has the same route of administration, pharmaceutical form and behavior as the original drug developed by a specific laboratory. Therefore, before it is registered as an authorized pharmaceutical product, the following features have to be proven to the appropriate National Health Authority.
The laboratory must duly show that it has a raw material, which is identical in its physical and chemical characteristics with the original drug, and also that it has the adequate purity. To do that the impurity profile must be perfectly stated.
A correct specification (determining parameters to control against acceptance criteria) of the raw material must be made, and a guarantee that the supplier is able to reproduce its quality must be provided.
The laboratory must then demonstrate that it is able to control that quality with duly validated methods.
Stability data of the raw material should be provided to assure that storage and transport conditions did not alter the product.
It is preferable for the product to have the same pharmaceutical form, although it is sometimes accepted for a generic product to have another pharmaceutical form, provided the route of administration and the physical status of the drug are the same. For example, a hard gel capsule may well be the generic product of a tablet.Although this may happen, it is easier to register a generic product that has the same pharmaceutical form as the original product.The finished product will not necessarily have the same composition as the original product, although they are the same pharmaceutical form.It is necessary to demonstrate that the manufacturing process is repeatable and that the drug replication is guaranteed. Therefore, it is obligatory to:
Specify and determine control methods, not only those belonging to the active ingredient, but also those of the excipients and primary container materials.
State the full formula, also that of volatile components, or those that may be volatile during the manufacturing process.
State the method of manufacturing and control.
Demonstrate the factibility of reproduction of the specified quality by means of the due validation of the processes involved. Determine critical parameters, which will be controlled during the manufacturing stage, to assure the generic product quality.
Submit the validation methods used for quality control during stability studies. It has to be demonstrated that these studies serve the purpose for which they were designed.
Demonstrate the product stability in the storage, transport and use conditions.
To assure that the generic drug will evidence the same behavior and consequences for the patients' health as the original pharmaceutical product, the validation through a clinical study is generally considered. However, it is not ethical to use patients and healthy volunteers to repeat this type of studies already made. Moreover, comparative clinical studies are not useful because:
It is difficult to determine its completion. To understand this concept well, let us turn to an obvious example: an antidepressant. When is it considered that a patient having a chronic depressive condition has been fully recovered?
Variability at later stages of the study is very high, consequently and to tackle that situation, a larger sample should be used as subjects for this clinical study. As noted above, a deceptive comparative clinical study may be designed which may not indicate a clinical difference when the variability of responses to the drug is very important. Therefore, we can conclude that this type of studies is not conclusive at all with respect to the drug effects.
Therefore, for some pharmaceutical forms in-vivo/in-vitro bioequivalence studies are requested.
Yes. The Health Authorities require that all products must be safe and effective. As generic products use the same active ingredients as the original products, they behave in the body in the same way, providing the same benefits and having the same risks and contraindications for patients as the original product.
No. The Health Authority requires that all products must have the same concentration, purity and stability as the original product.
No. Generic products behave the same way and require the same time to achieve a therapeutic response as the original ones.
No. The Health Authorities have only one set of rules and regulations known as "current Good Manufacturing Practices" (cGMP) which apply to both original and generic products.