Generics (generic medicines, generic drug equivalents) are equivalents of original medicines that may come on the market after their patent protection has expired.
Generic medicines appear on the market either as branded, with their own trademark, or unbranded, using a simplified name of the active substance concerned. They have become part of the health systems in most countries and contribute significantly to reducing the cost of medicines and improving the quality of healthcare.
The principle of essential similarity to the original medicine is most often used in the development and registration of generic equivalents. Essential similarity is based on three assumptions:
Qualitative and quantitative identity in the active substance. Consistency in the active substance means that the active substance in the generic equivalent must be of identical chemical structure, identical physicochemical parameters and in the purity defined by international guidelines. The substance must pass stability tests and be manufactured according to the principles of Good Manufacturing Practice. The development of an active substance very often involves the optimisation of the synthetic process and the creation of proprietary process patents.
Same dosage form. Consistency in dosage form means not only consistency in the route of administration (e.g. oral, injectable, etc.) but especially in parameters affecting the bioavailability of the product, such as dissociation profile, disintegration, acid resistance, controlled release of the active substance, etc. Also in this area, companies producing generic equivalents are coming up with a number of innovations and patented processes.
Bioequivalence. From a therapeutic point of view, the demonstration of bioequivalence, which is the agreement in the time course of the blood levels of the original drug and the generic equivalent, is very important. Bioequivalence studies also follow well-defined and internationally valid rules.
From the end-user’s point of view, it is important that the demonstration of substantial similarity confirms the therapeutic equivalence and interchangeability of the original medicine and the respective generic equivalent. The quality, safety and efficacy of the generic equivalent is assessed in the registration procedure, which has been carried out in the Czech Republic for many years under EU rules. The issuance of a registration certificate confirms that the medicine complies with all strict and internationally applicable regulations.
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