March 18, 2009 > With follow-on biologics, put patients first
With follow-on biologics, put patients first
By Karen Vicari
Roughly 70 million Americans suffer from arthritis. With more than 100 forms, it's one of the most common chronic health problems in the nation. And it doesn't just afflict the old - two-thirds of those with arthritis are under the age of 65, including 300,000 children. In fact, no other disease or condition causes more disability among Americans over the age of 15.
Arthritis patients like me are desperate for help. And while there is currently no cure, there are a few highly-effective treatments that significantly improve quality of life. The most promising of these are a class of drugs called biologics. Biologics are successfully treating cancer, Crohn's Disease, multiple sclerosis, and other ailments that used to be untreatable. And they hold enormous potential for vanquishing other diseases in the future.
For those of us who live with the chronic pain and fatigue of arthritis, biologics are a small miracle. But they are not inexpensive or easy to make.
Because they're manufactured from intricate compounds like proteins, biologics are far more complex than the small-molecule drugs that doctors typically prescribe. And unlike conventional drugs, biologics aren't cooked up in a lab using beakers and common chemicals - they're grown in living organisms, such as plant or animal cells.
Biologics are so complicated that they cannot be copied identically. With so many atoms comprising each molecule of a biologic, the potential for structural deviations within a batch of biologics is great. For example, it's not uncommon for arthritis sufferers to notice mild differences in each dose of their particular biologic - even though every dose is technically the same.
To help drive down healthcare costs, there is a push to allow the sale of cheaper, similar versions of brand-name biologics, called "follow-ons." While this is a great idea, it is imperative that policymakers move forward with care so that millions of patients are not put at risk.
The biologic that I currently take has been approved by the FDA after years of independent safety testing. Yet some of the proposals to regulate follow-on biologics require no independent safety testing of the new product. This could have disastrous consequences.
If two doses of a branded biologic can have a notable difference in their effectiveness, imagine how big the variations could be among follow-ons, which could be made in an entirely different manner from the original.
For those who rely on biologics, the thought of taking an imprecise or untested follow-on can be frightening. Any small change in a biologic could dramatically affect an already compromised immune system, thus putting a patient at risk for disability or worse.
In addition, some current proposals would legally classify follow-on biologics as "interchangeable" with the originals. Insurers would likely cover only the follow-ons, since they will likely be cheaper than the originals.
When it comes to medicine, one size does not fit all. If a person does not respond to a follow-on biologic, he or she should not be denied access to the product which has been proven to work. This is especially important for arthritis patients, as delays in taking an effective medication can cause serious problems.
Of course, that doesn't mean Washington should ban follow-ons. They could be just as useful and cost effective as generic versions of conventional pharmaceuticals.
But it's critical that Congress establish a regulatory framework for follow-ons that puts patient safety first by requiring them to be tested for safety and effectiveness. Further, lawmakers should establish coverage guidelines for insurers so that patients aren't denied effective treatments because of cost considerations.
Biologics have been a small miracle for those of us suffering from arthritis, allowing us to enjoy our lives without agonizing pain. By instituting sensible regulations for follow-on biologics that puts patient safety first, lawmakers would preserve the promise of biologics for arthritis patients - and for the millions of others with diseases that could be treated or even cured by biologics.
Karen Vicari is the executive director of Cure Arthritis Now!, a nonprofit arthritis advocacy organization.