Generic and original medicines – equally safe and efficacious
25.09.2014
The Agency for Medicinal Products and Medical Devices (HALMED) wants to provide hereby the information regarding the quality safety and efficacy of generic medicinal products in order to better clarify this issue:
Every medicinal product, regardless if it is an original or generic one, may be granted marketing authorisation and be accessible to patients, only if its safety and efficacy has been proved.
The generic medicinal product is a medicinal product containing the same amount of the same active substance as the original medicinal product acting in the same mechanism, same velocity and same efficacy as the original medicine. Generic medicines are equally well investigated and controlled as original medicines. Before being placed on the market, generic medicines must undergo bioequivalence studies, or clinical trials on patients where their equal efficacy to the reference original medicines must be proved.
The most important component of every medicine is its active substance. The active substance is a substance by which certain medicine achieves its therapeutic effect, it carries the therapeutic efficacy of the medicine. The generic medicine contains the same identical active substances in the same amount as the reference medicine, thus achieving an identical therapeutic effect. On the other side, in addition to the active substance, every medicine contains so called excipients without any therapeutic effect and therefore excipients may vary in certain generic medicines and their respective originals. So, only difference in the composition of generic and original medicines may be in their excipients used in their manufacturing, such as colours used to obtain different colouring of tablets to make them visually different, which is recommended for their easier differentiation. All these excipients of the generic medicine may obligatory fulfil the same criteria of quality and safety in the same manner as those in the original medicine.
Unfortunately, there is no medicine, for which we are sure that in no case it will cause adverse reactions, or that in certain cases the use of the medicine will not have any side effect on the user’s health and quality of life, regardless is it an original or generic medicine. The agency monitors all adverse reactions and safe use of generic medicines in the same manner as for original medicines.
Adverse reactions to medicines are mostly caused by active substances, and therefore patients react equally to the generic medicine as to its original. However, in exceptionally rare cases, in a very low percentage of patients, hypersensitivity reactions to certain excipient may occur. Due to possible differences in excipients of a generic and original medicine, certain patients tolerate better generic or original medicine, depending to what excipient the adverse reaction has been developed. So, for some patients is better the original, for some other generic. Therefore, it is in our interest to have a wide range of generic versions for every original medicine on our market and therefore a wider choice for our patients.
An original medicine may be placed on the market only after expiry of data exclusivity period of its reference product, thus enabling to manufacturers of original medicines to return what they have invested in the research and development of the active substance, which is a major cost in manufacturing and development of certain medicinal product. Taking account that the active substance is already developed by originator, generic manufacturers do not have the same initial investment costs in development of their medicines and therefore prices of generic medicines are usually lower than those of original ones.
The authorisation of generic medicines leads to a greater competiveness of the pharmaceutical industry, which contributes to lowering of prices of medicines and it is largely beneficial to all stakeholders of the healthcare system.
