The generic drug works in the same way as its prototype, but it is cheaper, which saves patients and the healthcare system, specialists emphasized on Monday at a press conference. Life cycles of drugs. Reference, generic and biosimilar drugs.
The press conference was held as part of the nationwide Drug Safe campaign organized by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
For an innovative drug to be developed, two stages are needed: preclinical and clinical research – said the head of the Department of Experimental Pharmacology at the Institute of Experimental and Clinical Medicine of the Polish Academy of Sciences. M. Mossakowski, prof. Paweł Grieb.
Pre-clinical studies account for 25 to 55 percent. drug development costs. At this stage, an average of 10 thousand people have to be synthesized and tested. compounds, checking their action on experimental animals, isolated organs or cells.
Later, there are three more phases of clinical trials on increasingly larger groups of patients (which generates 45 to 75 percent of the costs) – said Grieb.
He added that it could take up to 16 years from filing a patent application to registering a drug, and that the average cost of research is $ 1,2 billion (sometimes up to $ 2 billion). Even the successful results of all three phases of research on several thousand people do not guarantee that no problems will arise after registration and launching it on the market. It has happened several times already; most recently with the anti-inflammatory Vioxx, which was supposed to protect the stomach but damaged the heart in some people.
As the professor explained, drug patent protection lasts on average 8-10 years. During this time, the manufacturer tries to cover the costs and earn as much as possible on it.
When patent rights expire, other manufacturers may start making the same preparation – then it is called a generic drug. When a generic appears on the market, its price drops sharply (sometimes even by 90%). The producer of generic no longer incurs costs related to expensive clinical trials. Just recreate the replacement. Its production costs are a tiny fraction of the price demanded by the originator drug manufacturer, Grieb explained.
Thanks to generics, the costs of treating certain diseases are reduced, and the money saved can be spent on the treatment of other diseases with expensive innovative drugs. On the scale of the European Union, savings related to generics are estimated at USD 35 billion – said prof. Grieb. – A special case is biological drugs, complex compounds produced by living cells. In their case, generics are drugs + biosimilar + with the same effect ”.
Head of the Department of Pharmacological-Toxicological and Bioequivalence Assessment at the Office for Registration of Medicinal Products, Michał Czarnogórski assured that generic drugs contain the same active substance with already known properties.
They must have the same effect as innovative drugs and must have proven bioequivalence, i.e. achieve the same concentration in the blood – said Montenegro.
He also assured that the generics authorized for marketing are not dirty, i.e. they do not contain more impurities than the original drugs.
They cannot be called fakes. These are full-value, cheaper substitutes for innovative drugs – emphasized Montenegro. – They may differ with the packaging, but in general they differ from each other as well as the current in two different electrical sockets, i.e. not at all.
In order to identify a drug equivalent that can be used interchangeably with it, it is enough to compare the data on their packaging regarding the dose, action (e.g. 500 mg), pharmaceutical form (e.g. coated tablets) and international name (e.g. cefuroximum) – said Montenegro. (PAP)