To more than half a million patients suffering from rheumatoid arthritis or Crohn’s disease, Remicade has brought life-changing treatment and relief.
But the drug, a genetically engineered protein produced not by chemistry but by living cells in a manufacturing process that requires 310 discrete steps, also brings a heavy financial burden. The manufacturer estimates that each patient will pay $14,000 to $16,000 a year for Remicade, and that people generally will take it indefinitely.
For those helped by Remicade, made by Centocor Inc, a biotech subsidiary of Johnson & Johnson, the drug represents a realisation of the promise of biotechnology — to treat disease with laboratory-created versions of proteins and other essential building blocks of the body’s cells. But for employers, health insurers and the already stressed Medicaid and Medicare programmes that pay the bills, the drug represents something else — a serious threat to their financial well-being. With complicated and costly ‘‘biologics’’ such as Remicade increasingly seen as the wave of the pharmaceutical future, health care experts warn that they will drive the nation’s fast-growing bill for drugs far higher.
And that prospect has set off a fierce battle in Washington over the multibillion-dollar question of whether to open the door to lower-cost generic or ‘‘follow-on’’ versions of the pricey biologics.
Faced with a similar problem 20 years ago, when the prices for an earlier generation of drugs skyrocketed, Congress passed the Hatch-Waxman Act — which allowed makers of generic drugs to copy medications after the expiration of their patents and to sell them without conducting many of the expensive clinical trials and testing procedures that can make brand-name drugs so expensive.
Last year, about half of all US prescriptions were for generic drugs, yet those low-priced products accounted for only 8 per cent of the nation’s drug bill. Biotech drugs were in early development then, and nobody thought to give the Food and Drug Administration the authority to establish a similarly abbreviated review process for their generic versions.
‘Vampire bat’ biotech co draws blood in debut
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• Frankfurt: Paion, a German biotech firm that is developing an anti-stroke treatment from the saliva of vampire bats, became the first company to go public in Germany this year, with shares moving higher today on their first day of trading on the Frankfurt Stock Exchange. in late morning trade, shares in Aachen-based paion were changing hands at 8.39 euros, comfortably above their issue price of 8.00 euros. —AFP |
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Now, many believe the science of biopharmaceuticals — which has produced more than 150 FDA-approved drugs and has another 350 in human clinical trials — has advanced enough to make possible a parallel shortcut that would get lower-cost biologics onto the market. But others say that because newer biologics are much more difficult to manufacture and pose more safety risks, that prospect should worry the public.
Johnson & Johnson is pointing to its own experience with another product as a cautionary tale: patients taking its genetically engineered anemia drug, Eprex, experienced serious side effects after it started using a new stabilizing chemical, and it took years to diagnose the problem. —LAT-WP