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Generic medicines and equivalence

Submitted by admin on Thursday, 12 November 2009No Comment

Generic medicines and equivalence
Fierce competition in the pharmaceutical market, explains that the issues of interchangeability of drugs have become the most slippery issues of conflict and the industry. Manufacturers of drugs unleashed a kind of information war, which reflect the two main fronts. The first is between drugs within the same group, and the second – between the original medicines and drugs, reproduced (generics). A striking example of these “military” actions can serve as a market situation statinovyh drugs. Indeed, the effectiveness of drugs after a triumphant holesterinsnizhayuschih research the past 10 years under almost certainly not intended. This market is currently co-exist several more or less equally effective drugs that help reduce the atherogenic cholesterol. In principle, the question of choosing between atorvastatin, pravastatin, or simvastaninom flyuvastatinom (drugs listed in alphabetical order) – is largely a question case. However, the direct and hidden advertising mislead consumers that atorvatatin – is “most powerful” drug, lovastatin “less toxic”, pravastatin “safer”, and simvastatin – “the most studied. Is it true? Probably only in part. However, fierce competition within the group led to the fact that cerivastatin, in regard to safety two years ago there was some doubt, departed from the market almost immediately, and the echoes of the stories heard and to this day. At the same time two other drug manufacturers in this group were explicitly warned by FDA about the inadmissibility of the use of the principle of transfer properties of drugs, typical for the group as a whole on the properties of a drug. Within this same group exemplifies the dissonance between the true and surrogate endpoint of the study: the advantage of speed and power reduction of atherogenic lipids has no direct correlation with the frequency of adverse outcomes.

Expiration of patent protection has led to that market, a considerable number of generic drugs statinovyh. And here the fighting went on another – more subtle and less understandable to practitioner level. Widely discussed issues began to be added to the tablet form of some components, which in the opinion of one company are just the same poisons. And according to another – added to the dosage form in an amount to one hundred times less than the maximum allowable. Explanations of the benefits of the original drug reproduced sometimes seem totally transcendental, but the argument of the company-developer of the original drug can understand and accept. Colossal funds that are spent searching for the manufacturer of the molecule drug substance, the study of medicine and its excretion in the market, careful monitoring of possible adverse effects and interactions of drugs – all of these funds over several years, during which continues to operate, patent protection, are irretrievably lost . Generic drugs, which are beginning to play a few companies at the same time, a priori “inherit” all the properties whose presence in the preparation of the original proved with huge costs. And then you can arbitrarily long argued that the original is always original, and the reproduction means – just reproduced means. The presence of general international nonproprietary names (INN) makes these drugs are absolutely similar in the eyes of the end user, that seems fair, given that often the original and generic drugs are made from the same substance.

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