Original drug is an international term used for a new drug that has been proven to have a positive effect on a particular disease after extensive research and clinical studies; which is based on a patented molecule and which previously had no other similar drug.
In many countries worldwide, original drugs are protected for a certain period by strong laws, under the umbrella of patent and data protection rights. Within this period, it is not permitted for any other pharmaceutical company to manufacture this drug. Thus, manufacturers of an original drug are able to meet their R&D expenses and create resources for further research.
When the legal protection period for the original drug expires, pharmaceutical companies may launch its equivalents. These are called “generic drugs”. Companies manufacturing these generic drugs have to comply with certain rules in order to market them:
- A generic drug should contain the same active substance in the same quantity as the original.
- Its bioequivalence with the original drug should be proven.
- Generic drugs whose bioequivalence is proven are marketed without any research expenses amounting to hundreds of millions of dollars, and based on the proven efficacy and safety of the original drugs. Therefore, generic drugs may cost far cheaper.
The pharmaceutical industry needs both original and generic drugs in order to increase the quality of life for people. While original drugs offer a new, effective, and safer treatment to humanity generic drugs constitute an economical alternative. This relay should be able to function in a healthy cycle in order for the quality of life to be increased.