Generic and Original Medicinal Products - Equally Safe and Efficacious
Every medicinal product, regardless if it is original or generic, may be granted marketing authorisation and be accessible to patients, only if its safety and efficacy have been proved.
Generic medicinal product is a medicinal product containing the same amount of the same active substance as original medicinal product, acting in the same mechanism, with the same velocity and the same efficacy as original medicinal product.
Generic medicinal products are equally well investigated and controlled as original medicinal products. Before being placed on the market, generic medicinal products must undergo bioequivalence studies, or clinical trials on patients where their equal efficacy to reference original medicinal products must be proved.
The most important component of every medicinal product is its active substance. Active substance of a medicinal product is a substance by which it achieves its therapeutic effect, it carries the therapeutic efficacy of a medicinal product. Generic medicinal product contains identical active substances in the same amount as reference medicinal product, thus achieving an identical therapeutic effect. On the other hand, in addition to active substance, every medicinal product contains so-called excipients without any therapeutic effect, therefore excipients may vary in certain generic medicinal products and their respective originals. Hence, the only difference in the composition of generic and original medicinal products 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. At the same time, all the excipients of a generic medicinal product need to obligatorily fulfil the same criteria of quality and safety in the same manner as those in an original medicinal product.
Unfortunately, there is no medicinal product, for which we could be certain that it would not cause adverse reactions in any case, or that in certain cases the use of a medicinal product would not have adverse effects on user’s health and quality of life, regardless if it is an original or a generic medicinal product. Agency for Medicinal Products and Medical Devices monitors all adverse reactions and safe use of generic medicinal products in the same manner as for original medicinal products.
Adverse reactions to medicinal products are mostly caused by active substances, therefore patients react most often to generic medicinal products in equal manner as to its reference product. However, in exceptionally rare cases, in a very low percentage of patients, hypersensitivity reactions to certain excipients may occur. Due to possible differences in excipients between a generic and an original medicinal product, certain patients may tolerate better the generic medicinal product and others the original medicinal product, depending on the excipient to which an adverse reaction has developed. In other words, the original medicinal product may be more suitable for some patients while the generic medicinal product may be more suitable for others. Therefore, it is in our interest to have the widest possible range of generic versions for every original medicinal product in our market, which also implies as wide a choice for our patients as possible.
A generic medicinal product may be placed on the market only after expiry of data exclusivity period of its reference product, thus enabling manufacturers of original medicinal products to return what they have invested in the research and development of active substance, which is the major cost in manufacturing and development of a medicinal product. Taking into account that active substance is already developed by the originator, generic manufacturers do not have initial costs of investment in the development of medicinal products, which can last as long as 15 years, therefore prices of generic medicinal products are usually lower than those of original medicinal products.
Authorisation of generic medicinal products results in greater competitiveness on the market between manufacturing companies, which additionally contributes to reduction of prices of medicinal products and is largely beneficial to all stakeholders within the healthcare system.
Almost all medicinal products produced by Croatian Manufacturers are generic medicinal products. All of them are well-known and verified medicinal products that we have been using for a great number of years.
