Generic - Reference Pharmaceuticals
What is a generic pharmaceutical?
Generic pharmaceuticals are medications that have been scientifically proven to have the same properties as the reference pharmaceutical and therefore provide the same therapeutic results on the patient and are presented for sale after the protection periods of the reference pharmaceuticals have expired.
A generic pharmaceutical has the same effectiveness, quality and reliability as its reference pharmaceutical.
What is a reference pharmaceutical?
A reference pharmaceutical is a product that has been developed by an innovator company and provided for the market under patent protection. After the protection periods have expired these products may be taken as a reference to produce generic pharmaceuticals.
Is there a difference between generic pharmaceuticals and reference pharmaceuticals?
All of the phases that are generic pharmaceuticals go through from production until it is presented for sale, show all the same stages that a reference pharmaceuticals go through, only the clinical studies that are performed on living organisms by reference pharmaceutical producers are not done.
Currently the repetition of clinical studies that are successfully conducted by reference pharmaceuticals producers on live subjects by the generic pharmaceuticals producers is not considered to be suitable in terms of ethics and public health.
All of the studies and research that is considered to be necessary by health authorities are being done on generic pharmaceuticals and that fact that these pharmaceuticals provide the same treatment as the reference pharmaceutical on the patient is being proven with biogeneric studies. Biogeneric studies are the proof that a generic product provides the same treatment as the reference product or in other words is the therapeutic equivalent.
| Licensing Requirements | Reference | Generic |
|---|---|---|
| Company General Information | + | + |
| Product properties (Prospectus, label, package) | + | + |
| Expert Report | + | + |
| Pharmaceutical composition | + | + |
| Good Manufacturing Processes (GMP) | + | + |
| Inspection of starting materials | + | + |
| Inspection of finished product | + | + |
| Stability tests (Active material and finished product) | + | + |
| Comparison of generic product with reference product | + | |
| Pre-clinical studies | + | |
| Clinical studies | + | |
| Bioequivalence | + |
What is Bioequivalence?
Bioequivalence is considered the guarantee that a generic product and reference product achieve the same treatment, other words bioequivalence.
The two pharmaceuticals that contain the same active ingredient, in the same amount, in the same or similar pharmaceutical form and when administered to the body have the same speed of transfer to the blood from the area of application and are within certain limits are bioequivalent to each other.
In our country the “Regulation on the Assessment of the Bio-benefit and Bioequivalence of Pharmaceutical Preparations” was published in 1994. The requirement to have bioequivalence studies done has been put into practice retrospectively in the interest of public health. The Ministry approval process for bioequivalence studies on the said products is ongoing and there are no products that have been determined not be bioequivalent and recalled from the market in these assessments.
