First of all, because it is vital to human life and health, it takes a very long research and development process behind the birth of a new drug, and through large-scale clinical research, it has been confirmed that this drug is effective and safe for human body. -Dr. Frank Douglas, winner of the "Best R&D Director in the Global Pharmaceutical Industry of the Year" in 20065438+0 and 2004, said that it often takes 10- 15 years for a new drug to be born. On average, only 1 of every 9 drugs that enter clinical trials has a chance to be successfully marketed. Only large pharmaceutical companies with abundant funds can bear such high and risky R&D costs.
This drug, which has been clinically tested for more than ten years, is called "patented drug". Patented drugs usually enjoy a patent period of 20 years and have exclusive market rights. During the patent protection period, only this developed manufacturer can produce this drug.
Although the cost of producing drugs alone will not be high, manufacturers and pharmaceutical companies must recover the cost of drug research and development during the patent period, so the price of drugs during the patent period is usually relatively high, and not everyone can afford high drug prices.
Original research drugs and generic drugs, but fortunately, other manufacturers can also prescribe drugs with the same efficacy according to the formula put forward by the original R&D pharmaceutical factory when applying for a patent. At this time, this kind of medicine made by the original manufacturer with expired patents is called "brand medicine". Drugs produced by other qualified pharmaceutical companies with the same composition and technology are called "generic drugs".
Unlike new drugs, generic drugs need long-term clinical trials. Only two tests-drug bioavailability (BA) and bioequivalence (BE) are needed to prove that it has the same curative effect as the original drug.
Bioavailability, BA): refers to the rate and degree of absorption of active ingredients of drugs from preparations to systemic blood circulation or action sites. If it is a drug without systemic absorption, it refers to the index evaluated by the speed and degree of effective components reaching the site of action.
Bio-equivalence (BE) means that two drug equivalents or drug substitutes have the same bioavailability when given to human body in the same molar dose under the same conditions under appropriate research and design.
Because there is no long-term clinical trial, the production cost of generic drugs is much less than that of the original drugs, and they can be sold at the price of110 or even lower, and the cheap drug price makes more people affordable.
However, is the generic drug 100% equal to the original drug? The answer is no, because the manufacturer of the original drug didn't announce the content of 100% when applying for the patent, but these ingredients not written in the patent content are often one of the important factors that make the drug work, which is also the reason why the generic drug ≠ the original drug.
Generic drugs? Original medicine? Which is better? Some people may ask, is the production equipment of generic drug manufacturers poor? The answer is no, at present, the well-known domestic drug manufacturers have obtained GMP certification, and both the process and equipment have a very high standard. In terms of safety, generic drugs must be strictly examined by the health authorities before going on the market, and their components and action principles are the same as those of the original drug, so their safety and possible risks are the same as those of the original drug.
So, is the efficacy of generic drugs the same as that of the original drug? According to the reply given by the famous pharmaceutical association of the Republic of China, the answer is yes. Because generic drugs are approved drugs produced by other qualified pharmaceutical companies with the same ingredients and processes, their uses, dosage forms, safety, efficacy, administration routes, quality and other characteristics can be exactly the same as those of the original drugs, so the efficacy will be equally effective.
This view is obviously different in the medical field, and there are many voices pointing out that generic drugs are not as effective as the original drugs, so I won't analyze them here. However, because each imitation pharmaceutical factory has different requirements for drugs, some may only get 60 points, and some may get 80 points, so it is impossible to generalize. We can only say that generic drugs are legal and qualified in terms of laws and regulations.