Generic yes, counterfeit no!

The introduction of one or more generic versions of Sildenafil will likely have an impact on the amount of branded blue pills sold, but it is also foreseen that this will impair the number of boxes that are illegally sold on Internet. «Well this matter is much more complex than it seems to be – said Dr. Mondaini – first of all, we must clearly distinguish among the originator drug, Viagra in this case, its generic versions, and the drugs that you can find on the Web. When you talk about generics you are taking in account a drug that is analogue to Viagra in terms of safety and efficacy, where sometimes there are only few differences in the excipients that compose the formulation. Of course differences do exists, and these make the efficacy profile of generic drugs, usually, slightly lower. Drugs sold on internet are a completely different story! They are not sold through official channels and, therefore, are dangerously uncontrolled. There is an Italian study (IMPACT Italia) highlighting that purchasing drugs on the web turns in a simple loss of money in 50% of times, meaning that you will never get what you have ordered. But in the other half of times (and maybe this is the worst case scenario) in the minority of cases you will get the real molecule at lower doses while in most of cases you will find a mix up of substances that in many cases are dangerous. In our Country this kind of e-commerce is forbidden and also people that buy drugs on Internet commit a criminal offence which is punishable by law.

To understand in which extent generic Sidenafil will impact on Italian online marked of drugs for Erectile Dysfunction, one has to understand why people do it. Among the reasons that drive people to buy drugs online, and Viagra is one of the most popular (if not the most popular ever), there is shame to buy it in pharmacies, the belief that it is legal and the desire to save money. In this view, the introduction of generics will only have impact on the latter population, but I do not believe that the online market will suffer for this. With respect to other European Countries, Italian online market of drugs is much less widespread, but data tell us that there is a general trend to increase, regardless the introduction of generic drugs. In my opinion the main reason for this is that people are not aware that procedure is not legal».

It is worth of note that Pfizer recently announced that to increase its war against counterfeit Viagra sold on the Web, it will soon start to distribute in the U.S. the blue pill online, directly through their own channels, of course only to patient that received a regular medical prescription.

GENERIC DRUGS: A MATTER OF BIOAVAILABILITY

Several years after the introduction (2002, in Italy) of generic drugs doubts often persist, both in patients and doctors, concerning the overall similarity to the originator drug, the interchangeability, the overlap of effectiveness and the safety profile.

So, maybe, we can start with the definition: generic medications are bioequivalent “copies” of originator drugs that can be placed on the market after the expiry of the patent protection. These drugs must have the same qualitative and quantitative composition in active substances (the various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered the same active substance), the same pharmaceutical form and the same therapeutic indications. So basically, the sole differences between branded drug and its generic version are the excipients inside the specific pharmaceutical form. It should indeed be noted that, to become a generic, you just have to demonstrate thorough specific bioequivalence clinical trial that your bioavailability is pretty similar to your refernce originator. To be a bit more technical, the 90% confidence interval of the area under the plasma concentration curve (AUC) and the plasmatic concentration peak (Cmax), between the originator and its generic must be between 0.80 and 1.25. This “acceptable range” of bioequivalence was chosen because it is assumed that the intraindividual and interindividual variability can arrive at a value close to about 20%. Of course this system may have some limitation especially for drugs characterized by a high intrinsic pharmacokinetic variability and / or by a very narrow therapeutic index, ie concentration of drugs whose effectiveness is very close to that of toxicity (eg: curare drugs, antineoplastic, digitalis, immunosuppressants, etc.).