Introduction
A drug that is structurally similar to drugs already known, with minor differences. The term “me-too” has a negative connotation. However, me-too products may create competition and drive prices down1.
The majority of new products in the industry are removed one? ŢÕõÀ Me? Drugs that are almost identical to current treatments, but â? not treated better than drugs already on the market under the same conditions. â? About 75 percent of new drugs approved by the FDA are me-too. You may be less effective than current drugs, but as long as Thei? Re effective than placebo, they can get the regulatory green light2.
This nâ? T surprising at all, as someone who works in the region, but these so-called â? ŢÕõÀ Me? Drugs that are supposed to be better than their ancestors, driven up costs. A a? ŢÕõÀ Me? Drug is a drug that originated in another drug. The most famous example is Prilosec (â? The Purple Pilla ????) and Nexium (â? Todai? Purple S Pilla ????). Prilosec? S drug omeprazole. Nexium? S drug called esomeprazole. The difference is that Nexium is left-handed version of omeprazole. In chemistry, the S stands for sinister, meaning that the molecular conformation is a left orientation. (D is right handed.) So, this S-omeprazole is half the mixture, which was its predecessor. By selectively choosing the S-conformation, the drug is enhanced. That sounds good, but their efficacy is only marginally better than Prilosec, which has a generic version, and costs about one third less than Nexium. Some of the other? ŢÕõÀ Me? Drug: Claritin (loratadine) and CLARINEX (desloratidine), Celexa (citalopram) and Lexapro (escitalopram) 3.
What are the “me too” drugs?
Since the advent of modern chemotherapy, where drugs were discovered and developed through the process of sorting thousands of molecules for a variety of disease conditions using animal models, there was a growing criticism that have been too many molecules with similar chemical structure and has developed the same pharmacological profile, with very little to distinguish them in terms of therapeutic benefit. In other words, once the first breakthrough discovery of a new pharmacological activity of a new molecule, subsequent years saw the emergence of a multitude of new molecules or “me-too” drugs of the same chemical class and have the same pharmacological profile.
In monitoring drug was known molecular changes, roulette or molecular mimics, are the development, which are allegedly based on purely commercial considerations. They are also considered to reduce the innovation process to involve, in relation to the original molecule. It is important from a historical perspective, the end result of these efforts in different therapeutic areas to develop new molecular entities, which, as discussed later, the generation of products after a first breakthrough discovery has been made and the technical benefits, medical and economic development of such drugs.
Development of “me-too” drugs
The success rate of discovery of new chemical entities with fundamentally new chemical and biological profiles of activity are very low. In fact, even the chemicals in structural classes, even an approved drug increasingly rare over the period of the sixties to the eighties. In 2001, 26 billion U.S. was for the development of new drugs and the U. S. approved by the FDA spent only 9 new chemical entities. At the same time, two thirds of drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those in the more recent forms and formulations4.
Of the 1035 drugs approved by the FDA in 1989 to 2000, only 361 or 35% containing new active substances. Among them, only less than half were granted priority review by FDA. The impression is that these drugs are slightly modified versions of existing drugs, with little to offer in terms of improved activity and tolerance, let alone new pharmacological properties. The consequence is that they are developing such drugs as patents expire on the original best-selling drugs are discovered and really not much new drugs. The statement that many of these drugs do not offer significant advantages compared to other drugs through the refusal of the FDA a priority provide tests for most of them given.
Moreover, conventionally, regulators, and not required, including the FDA, better efficiency compared to existing drugs as a condition for approval, but they require only a determination of the efficacy and safety new drugs over placebo.
How good are they?
Despite these perceptions, historically, have many “me too” drugs revealed significantly better than their original counterparts. Examples include a number of generations of beta-blockers, which are released after the original drug Propanalol discovered by ICI, with most of them have substance to improve the efficiency, selectivity and cardiovascular safety vascular. Ranitidine, the first monitoring of drugs after the introduction of the first H-2-receptor antagonist cimetidine, in pursuit of famotidine and in any case, these “me-too drugs” has achieved remarkable results of original drug .
Besides the great breakthrough in the development of orally active beta-lactam antibiotics of penicillin and cephalosporin class in the same oral derived significant improvements were achieved by changes in side chains by condensation of specific agents with 6 – ABS are listed, 7-ADCA and 7-ACA. A series of new broad-spectrum antibiotics, such structural classes can be developed. In each of the major classes of antibiotics, according to the mechanism of action, inhibiting the synthesis of cell wall (beta-lactams, vancomycin), which inhibits bacterial protein synthesis (erythromycin, tetracycline, streptomycin) inhibitors of DNA or RNA replication classified (quinolones, rifamycins), inhibition of the biosynthesis of coenzyme folate (sulfonamides, trimethoprim), there have been several “me-too” drugs have been marketed.
Show an important recent example of this “me-too” drugs must be developed that is the case of oral hypoglycemic agents, troglitazone, approved as a medicine against diabetes in 1997. The drug was withdrawn from the market following cases unacceptable liver toxicity. Monitoring of “me-too” drugs, rosiglitazone and pioglitazone are much less toxic and are widely used today. If these drugs have not been developed, the withdrawal of troglitazone, he would have left a great void in the therapeutic treatment of diabetes.
”Me-too” drugs: Strategies for New Drug Research for Indian companies
Revolutionary innovations in the pharmaceutical industry, new drugs such as beta-blocker, first, the first NSAID, the first of each class of antibiotics, calcium channel blockers, ACE inhibitors, the sulfonylureas, biguanides, insulin, glitazones, Meglitinide, tricyclic anti – depressants Traquillisers majors, minors, selective inhibitors of serotonin receptor, H-1 and H-2-receptor antagonists, inhibitors of proton pump, etc. are relatively rare, and even if some of the original drugs in these classes are still in use, they are redundant in most cases by later generations of products, many of which are “me-too”. New drugs are discovered, both by incremental innovations on the original drug, as well as new research.
In general, the original discovery led to feverish activity in these two innovative companies as well as in laboratories of competitors to develop better products in the same therapeutic class. The major constraint to business success, however, that the newly discovered molecules should meet the minimum requirements for patentability. For example, within three years, the discovery of citrate Sildinafil very successful (Viagra), three other new indications for the same have been patented and developed5.
Me-too drugs and therapeutic advantage6. For practitioners, these are the benefits of the drug established for Agriculture, “me too” drugs, coupled with clinical trials, which – hopefully – to demonstrate patient-centered benefits such as profiles of ‘side effects, less frequent dosing less disruptive potential for drug interactions of drugs, and so on. A “me-too” drug is a hell of a lot easier to accept in practice, when a new medication7.
”Me-too” drugs: the hidden dynamics
The most common criticism of drug development based on the so-called “me-too” drugs that use the same biological mechanism to pioneer a brand. It requires more than one of these large targets, such as the ‘anti-anti-ulcer Nexium. We should think about antidepressants, anti-cholesterol treatment of diabetes, antipsychotic drugs and other therapeutic categories, which saw sales success and rapid innovation are. It some evidence that monitoring drug, many patients do much good. The newer statins, for example, often the performance of the elderly in clinical trials where the endpoints are the number of heart attacks and deaths prevented.
Me-too drugs are also a powerful tool to reduce costs in health care. We should be happy that our industry research is not only a new target of biological mechanisms. This model has been very costly business would, in fact. Fortunately, the industry is working on incremental improvements, use of opportunities to improve drug therapy and may open the door to radical improvements really are more or less adjacent to occur, scientifically speaking. In the meantime, we have price competition as a byproduct. Me-is almost always lower than the price of the pioneer drug.
Another part of me-too story is almost totally ignored, although it is extremely important. For me-too manufacturers, dedicated to the advancement of science is a way to gain competitive advantage. The classic example is the class of statin drugs against cholesterol. Research on one-on drug (Pravachol is to follow) for the first time with a statin to lower cholesterol would actually prevent deaths from heart attack, which had previously been accepted without proof. Additional tests for different statins, including Lipitor, Zocor and Pravachol, the serious threat, showed that serum cholesterol was thinking much more important than almost everyone (on the prevention of stroke, for example).
There are many stories about the benefits of new research on me-too, but they are part of a larger story: new uses for old drugs. The data show a slowdown in approval of new drugs do not include essential information: discoveries of new uses for old drugs. This type of discovery is now so widespread that there was a use “new” revolution amounts. One of the ironies of the new scientific era of pharmaceutical research is to approach as a medicine based on biological mechanisms, which are actually used more diverse. Because the body normally uses specific mechanisms, again and again, sometimes seemingly unrelated.
Consider SSRI antidepressants. A recent scientific article on the various applications and unexpected drug, violin with the reuptake of serotonin, which is what they have completed the SSRIs, the term “antidepressant” is misleading because there is no reason scientific thinking of the drug for depression. Fight against depression only happens to be the first really good condition that has been studied for a very interesting class of drugs.
Another example is the Cox-2 inhibitors like Celebrex (and Vioxx, which is important in this story, and may again) on the market, partly for this reason. They were invented to relieve arthritis pain. But COX-2 is important for many things, including cancer and Alzheimer’s. Clinical trials using these tracks to run for years. Celebrex is already approved to reduce the risk of colon cancer, and Vioxx has also obtained promising results. Of course, the big news recently that these drugs can cause heart attacks. But even here, me-too economy is of paramount importance. Traditional NSAIDs (non-anti-inflammatory drugs) such as Advil and Alleves can have the same risk of heart attack. The potential is there for decades, but only new drugs, Cox-2 were put through an extensive long-term clinical studies, because these are the only ones still under patent. This is an example of me-too drug development adds to research all have. Thank you to the me-too, we learn about anti-inflammatory drugs, heart attacks, cancer, and probably many more.
Also influenced by new uses are the new targeted cancer drugs that no such specific biological mechanisms, which they do) to avoid killing everyone in sight attack rapidly growing cells (such as conventional chemotherapy tends to be .
The consequences are clear. The annual number of approvals of new drugs will be a tick if a new cancer drug or a new statin gave his first admission. But a new use for an old drug may be as useful as a medicinal brand new and even more valuable if we consider that we learn more about the safety profile of older drugs and a drug is often the work of two orders (the prevention of two heart attacks and stroke), eg 8
Me-too products can sometimes have significant benefits of tolerance or dose. It could create more competition and lower prices. If you have five Me-toos, perhaps the sixth is something that is a little better. It plans to decide on behalf of their patients. And even if the same mechanism of action, could help bring more competition to reduce prices for the whole class. That’s? S an important role, with a healthy if possible, enhanced by improved access.
How are they bad?
Although the major problem of antibiotic therapy, namely, the resistance may not pass through the development of “me-too” drugs, the inclination of the same class resistance to develop, in most cases, the new semi-synthetic derivatives should be raised clear advantages over previous. To be useful, for example, first generation cephalosporins for Gram-positive infections, while second-generation drugs to cover a wider spectrum, including the Gram-negative organisms. The third generation of drugs designed to create resistance to beta-lactamase enzyme, as well as against some of the most serious infections, such as Pseudomonas and Klebsiella-pathogenic strains.
Even as the pharmaceutical industry is proving to families of me-too for relatively benign conditions in the rich, it almost pays not to serious diseases such as malaria, affect, impoverished people. There are also less profitable drugs is short, so there is now a shortage of some vaccines and rescue drugs9.
The big problem with me is against drugs that are chemically very similar to other drugs already exist, but they are marketed when they are important for further progress, with very high prices. Many new, expensive me-too is not necessarily better than older drugs and less expensive. Most of the time they are compared with placebos, and no comparison to older drugs.
”Me-too drugs” are for 80% of increased spending in recent years, responsible, and on average four times more expensive than comparable older alternatives10. With the review of patented drug prices (PMPRB) definitions , one at the time of introduction? drug ŢÕõÀ Me? were considered moderate, little or no improvement through – in terms of efficiency and security – compared to the previous alternatives. However, on average, A ? ŢÕõÀ Me? drugs cost about 2. 5 times more than comparable older drugs by prescription. The question is whether real or perceived differences justify the higher costs. New drugs have a role in some cases and in some patients . However, it is useful to older drugs also effective when possible11 use.
Modification of FDA regulations to discourage me too drug approval R & D would be much more expensive, would stifle competition and increase costs of health care, and would be the new wave of scientific research which has revolutionized our understanding of the prevention therapeutic categories where competition was more intense.
Conclusion
New drugs are not required to give old, and There? S is usually no way of knowing if they do. Although the FDA drug tests before they are marketed, they Dona? T were compared with similar drugs already on the market. The FDA requires only that they are appropriate and certainly better than nothing, act small. This gap in the FDA legislation opens the door to an unlimited number of me-too, which are lighter than innovative drugs to develop.
Since everything is therefore not surprising that this â dear? ŢÕõÀ Me? Drug costs money from the medical industry. The prevalence of me-too said, really a lot about the lack of innovation in the pharmaceutical industry. If you look at the new drugs over the last six years on the market, 78 percent are not even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the FDA as unlikely to be improvements over drugs already on pharmacy shelves.
At the same time, it lacks some important drugs that pharmaceutical companies are not much interested, because they are not as profitable as the me-too’s. But companies do not have the necessary medicines, if they are not lucrative. And they do not.
References
1. http://www. MedTerms. com / scripts / main / art. asp? articlekey = 33,748
2. http://www. Mother Jones. com/news/qa/2004/09/09_401. html
3. http://polyscience. org/2005/09/me-too-drugs
4. http://www. Shvoong. com/books/465475-me-too-drugs
5. http://www. pharmabiz. com / article / detnews. asp? SecArch = & ArticleID = 14604 & sectionid = 46
6. http://direct. bl. uk / bld / placeOrder.php. do? UIN = 162532605 & ETOC = RN & from = search
7. http://www. Archivum. Info / sci. med/2005-09/msg00257. html
8. http://www. AEI. org / publications / filter. Everyone PubID. 27443/pub_detail. asp
9. http://blogs. WSJ. com/health/2007/05/17/in-praise-of-me-too-drugs
10. http://www. CHEPA. org/KnowledgeExchange/LabelleLectureship/tabid/84/Default. aspx
11. http://www. ti. UBC. ca/pages/letter59. html