For those helped by Remicade, done by Inc. Centocor, a subsidiary of biotech of Johnson and Johnson, the drug represents an accomplishment of the promise of the biotechnology -- to deal with disease with laboratory-created versions about proteins and other essential blocks of building about the cells body. But for the patterns, insuring of health and the programs already tensionados of Medicaid and Insurance of disease that pay the accounts, the drug represents the something more -- a serious threat for its financial well-being.

With "biologics complicated and expensive" for example Remicade seen more and more like the wave of the pharmaceutical future, the experts of the medical care notice that they will far lead the account of fast crecimineto of the nation for drugs above. And that perspective has fixed of a ferocious battle in Washington on the multibillonaria question of the dollar of if to open to the door in the generic under-cost or the versions of the "continuation" of biologics of the pricey.

Fact in front with a similar problem 20 years ago, when the prices for a drug generation rose suddenly first, the congress passed the act of the Portilla-Waxman -- that allowed that the generic drug manufacturers copied medications after the expiration of their patents and that they sold them without leading many of the tests and the expensive clinical methods of test that they can make drugs of the so expensive trade name. The year last, over half of all United States the prescriptions were for generic drugs, those products to low price considered only 8 percents of the account of the drug of the nation yet.

The drugs of then Biotech were in the early development, and nobody thought to give to the administration of the food and the drug the authority to establish a similar brief process of the revision for its generic versions.

Now, many think that the science of biopharmaceuticals -- that has produced than 150 drugs more FDA-approved and has other 350 in human clinical tests -- has advanced enough to make a parallel short cut possible that would obtain biologics of the under-cost on the market. But others say that because biologics newer is much more difficult to make and to raise more risks of security, that perspective must worry to the public.

Johnson and Johnson are indicating to their own experience with another product as story cautionary: Some patients who took their directed genetic drug from the anemia, experienced Eprex, serious indirect effect after the company began to use a new chemical agent that became stabilized, and they took years to diagnose the problem completely.

This edition and will be more discussed in a conference of the FDA the next week, one designed to determine if the masters of the manufacturers of the generic-drug has progressed far enough to the taking in biologics.

Main the commercial associations of drugmakers of the trade name say that it probably does not have. "a biological one is very diverse reverso-engineer of the process to the pill that," said to James C. green Forest, president of the organization of the information of the biotechnology. "with a pill, you can discern rather easily the chemical maquillaje and later to duplicate the product. But with greatest, proteins more complicated and more variable than they above do for biologics, you you can obtain the small but significant differences very easily that they have clinical effects."

But the manufacturers of the generic-drug -- as well as some insuring and programs of the government who pay the accounts -- discuss that the industry foot- is dragging whereas science hurries next.

"I feel that we have science and the systems in place to make biologics and surely effective," I said Marvin Samson very strongly, vice president trains Ltd. phamacists, a generic manufacturer of Teva that already produces biologics in Eastern Europe for the countries in where the protection of the patent is not made fulfill. "the situation is like in years 80 with the Portilla-Waxman, where the industry of the trade name said that we did not have science and the capacities to analyze its products and to reproduce them. Then we had the capacity, and now."

The generic pharmaceutical association, that represents 120 companies, wanted that the congress soon created a process of the revision for biologics generic. "we thought that as policymakers understands better what biologics without the competition is going to do to the budgets of Medicaid and Insurance of disease, they will wish a generic option definitively," said Kathleen Jaeger, the president of the GPhA.

That the opinion is not shared extensively in congress. They do not convince portilla of Sen. Orrin G. (R-Utah) and Rep. Henry To Waxman (D-Calif.), patrocinadores of the law 1984, that exists a scientific consensus.