Issue of "generic" biologics, or biosimilars, will confront next Congress
Congress is considering several bills that would make it easier for companies to market generic versions of biologic drugs, according to a recent article in the Washington Post. Competition from generics is expected to reduce significantly the cost of expensive biologic medications. The Congressional Budget Office estimates that the availability of biologic generics would save the health care system $200 million by 2013 and $25 billion by 2018. But getting there poses significant challenges.
Generic versions of conventional pharmaceuticals are already commonplace. The 1984 Hatch-Waxman Act established a streamlined procedure for FDA approval of generic drugs. Once the patent on a brand name drug has expired, any company that can demonstrate that its generic is chemically identical to the original can market it without doing any further clinical testing.
Generally speaking, conventional drugs are chemically simple molecules and determining that a generic is identical to the original is straightforward. Biologics, on the other hand, are highly complex protein molecules. They are produced by manipulating cultured cells, a process that has so many variables that it is impossible to prove that one biologic is identical to another. Thus, the generic versions of biologics are known as "biosimilars."
Because biosimilars might be subtly different from the brand name drug they are imitating, some experts believe that biosimilars, unlike conventional generics, should undergo testing for safety and effectiveness before they are approved. Some patient groups are already campaigning to block insurance companies and pharmacies from forcing patients to switch from brand name biologics to biosimilars once they become available, a practice that is common for conventional drugs.
Currently, there is no legal framework in place to get a biosimilar to patients. Three bills outlining modified procedures for approving biosimilars have been introduced in Congress since last year. The major difference between the bills concerns "data exclusivity"--the length of time that must elapse before a generic drug maker is allowed to use the original manufacturer's clinical trial data in support of the generic product. Makers of biosimilars are pushing for five years; makers of brand name biologics are asking for 14 years. Biosimilars are not considered to be identical to the originals, so companies do not have to wait for the brand name drug's patents to expire before marketing an equivalent. That makes the data exclusivity issue that much more important.
A few biosimilars are already available in Europe. In France, about 20% of patients taking growth hormone have switched to a generic version.
For psoriasis patients and advocacy groups, the debate presents its own challenges. If you are taking a biologic successfully and have good insurance, you might not want to risk an untested "biosimilar" just to save your insurer money. Or if you are hoping the next generation of psoriasis treatments will be even better, you might want a profitable and robust biotech sector investing in tomorrow's cures; after all, generic drug companies don't invent anything, they just save the system money. Then again, if you are paying mammoth co-pays or currently cannot afford a biologic, you might be ready to march on Congress to get a generic-style version of psoriasis biologics to market. People might also differ based on how much testing they like to see conducted, and for how long, before they are willing to try a new treatment. Add to that the fact that patient groups receive contributions from biologics manufacturers, and you can imagine the controversy this issue creates.
"We believe it is essential that Congress move toward a legislative framework for approving safe and effective biosimilars," said Michael Paranzino, president of Psoriasis Cure Now. "Too many patients are not able to access biologics today, given their cost and the current state of health insurance. But as with most things, the devil is in the details. How do you ensure safety and effectiveness of a biosimilar? How many patients should test a biosimilar, and for how long, before it is made widely available? And who should decide if a patient should take a biologic or its 'generic' alternative? An insurer? The patient and the patient's doctor? We intend to be part of the dialogue and debate as this important issue is considered next year in Congress."
Generic versions of conventional pharmaceuticals are already commonplace. The 1984 Hatch-Waxman Act established a streamlined procedure for FDA approval of generic drugs. Once the patent on a brand name drug has expired, any company that can demonstrate that its generic is chemically identical to the original can market it without doing any further clinical testing.
Generally speaking, conventional drugs are chemically simple molecules and determining that a generic is identical to the original is straightforward. Biologics, on the other hand, are highly complex protein molecules. They are produced by manipulating cultured cells, a process that has so many variables that it is impossible to prove that one biologic is identical to another. Thus, the generic versions of biologics are known as "biosimilars."
Because biosimilars might be subtly different from the brand name drug they are imitating, some experts believe that biosimilars, unlike conventional generics, should undergo testing for safety and effectiveness before they are approved. Some patient groups are already campaigning to block insurance companies and pharmacies from forcing patients to switch from brand name biologics to biosimilars once they become available, a practice that is common for conventional drugs.
Currently, there is no legal framework in place to get a biosimilar to patients. Three bills outlining modified procedures for approving biosimilars have been introduced in Congress since last year. The major difference between the bills concerns "data exclusivity"--the length of time that must elapse before a generic drug maker is allowed to use the original manufacturer's clinical trial data in support of the generic product. Makers of biosimilars are pushing for five years; makers of brand name biologics are asking for 14 years. Biosimilars are not considered to be identical to the originals, so companies do not have to wait for the brand name drug's patents to expire before marketing an equivalent. That makes the data exclusivity issue that much more important.
A few biosimilars are already available in Europe. In France, about 20% of patients taking growth hormone have switched to a generic version.
For psoriasis patients and advocacy groups, the debate presents its own challenges. If you are taking a biologic successfully and have good insurance, you might not want to risk an untested "biosimilar" just to save your insurer money. Or if you are hoping the next generation of psoriasis treatments will be even better, you might want a profitable and robust biotech sector investing in tomorrow's cures; after all, generic drug companies don't invent anything, they just save the system money. Then again, if you are paying mammoth co-pays or currently cannot afford a biologic, you might be ready to march on Congress to get a generic-style version of psoriasis biologics to market. People might also differ based on how much testing they like to see conducted, and for how long, before they are willing to try a new treatment. Add to that the fact that patient groups receive contributions from biologics manufacturers, and you can imagine the controversy this issue creates.
"We believe it is essential that Congress move toward a legislative framework for approving safe and effective biosimilars," said Michael Paranzino, president of Psoriasis Cure Now. "Too many patients are not able to access biologics today, given their cost and the current state of health insurance. But as with most things, the devil is in the details. How do you ensure safety and effectiveness of a biosimilar? How many patients should test a biosimilar, and for how long, before it is made widely available? And who should decide if a patient should take a biologic or its 'generic' alternative? An insurer? The patient and the patient's doctor? We intend to be part of the dialogue and debate as this important issue is considered next year in Congress."
posted by Psoriasis Cure Now at 6:31 PM
0 Comments:
Post a Comment
<< Home