The decision to replace the original drug with the generic drug, and vice versa, should always be carefully considered. It is important that this is a therapeutic decision, not a commercial decision.
The drug market and the value of generic drugs
The simplest breakdown of the pharmaceuticals market is over-the-counter (OTC) and prescription (Rx) drugs. However, due to the registration qualifications, there are innovative and generic drugs as well as preparations with the so-called well established use. Companies producing innovative (original) drugs are of great importance in the development of new technologies. However, the pharmaceutical industry in Central and Eastern Europe is dominated by companies producing generic drugs (the so-called generics). Analysts say that the generic drugs market in 2008 was worth EUR 17.2 billion, and predict its further development. Also in Poland, generic companies have a large share in the pharmaceutical sector. Among many European countries, it is Poland that is the leader in terms of value and quantity of generic drugs sold. In terms of value, generic drugs constitute 88% of the drug market in our country, and in quantitative terms – approx. 66%, which is definitely more than in other countries (Fig. 1).
Generic drug manufacturers spend approximately 6-8% of their revenues on research and development to ensure the quality, safety and efficacy of their products. In addition, generics account for just over half (53%) of prescription drugs.
What are generics and how are they made?
It is worth considering why generics have dominated the pharmaceutical market. Generic drugs are called generics, equivalents or substitutes, or generics for short. They contain the same active substance, have the same form, dose, route of administration and indications as the original drugs. They may contain other excipients as long as they have no therapeutic effect. However, it is important to know that the use of other fillers may, in some cases, modify the action of a generic drug, such as its dissolution or absorption. As a result, this may lead to a change in the effectiveness of the drug and the occurrence of side effects. The shape, color and size of a generic drug may differ from the original drug – these features do not have any properties affecting the therapeutic effect.
The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices. However, in the United States, 19% of manufacturers had abnormalities in the manufacture of generics. Among other things, water pollution and insufficient quality control.