Interchemia Praha, spol. s r.o.

What are generic medicinal drugs?

Generic drugs are equivalents to original products which may come on to the market after patent expiry. They contain the same active substance, correspond to the same exacting rules in development, manufacturing, and at the safety assessment, and they possess the identical quality, safety, and efficacy as the originals do. Generic drugs come up on the market as branded generics, with respective trade marks, or as non-branded, exercising a simplified nomenclature of the respective active substance (e.g. diclofenac, metformin, etc.)

Where in is the significance of generic equivalents?

They are available for a lower price, therefore increasing accessibility for modern products. Generic equivalents are available for a price about 20% to 80% lower compared to the price of originals. Their quality, efficacy, and safety are nevertheless the same towards the original products. They back innovation and competition as they generate competition to original products. Hereto the originals would have permanent privilege there will be no argument for innovation. There is no contradiction in between generic and original drugs. Wider utilization of generic equivalents leads to savings, which might be utilized in wider use of more expensive original drugs where there are truly needed.

Why are the generic equivalents cheaper than the originals?

Originals are in monopolistic position while protected by patent that is why they have a greater feasibility in fixing a higher price. With generic equivalents there is no need to repeat all of the preclinical and clinical studies, and they can be cross-referred to clinical data of the original products. The development is therefore essentially cheaper.

How is the safety and efficacy of generic equivalents warranted?

Any medicinal product before a market release must pass through the registration (marketing authorization) procedure. In the entire European Community the registration procedure takes place at the authorized site – medicine control agency. Provided the medicinal product has been registered, by law has been warranted its safety, efficacy, and quality. Along the registration procedure identical criteria apply for generic equivalents such as for originals. The registration (Marketing Authorization) warrant is valid for 5 years. In the course of this time period the manufacturer is obliged weighing evidence for product safety not only for proper product but of all others containing the same active substance. Condition for renewal of registration (marketing authorization) is submission of an overall summary report on product safety for the past period.