The Pennsylvania Legislature is considering a measure to make sure patients have safe access to an important new class of drugs called “biosimilars.” If the bill passes, Pennsylvania will follow North Dakota, Oregon, Utah and Virginia in taking this critical legislative action.
“Biosimilars” are copycat versions of biological drugs, and the Food and Drug Administration is slated to begin approving these highly effective treatments next year. They’re expected to hit pharmacy shelves costing about 30 percent less than the brand-name medicines they’re based on. The benefits for patients, especially those suffering from cancer and other debilitating illnesses, could be enormous.
However, biosimilars do present some unique health risks. The immense chemical complexity that makes them so powerful can also, on occasion, generate adverse auto-immune responses. The Pennsylvania bill accounts for that medical reality and requires a simple, commonsense safeguard: Physicians and their patients should be notified in the event a pharmacist swaps out a prescribed biologic for its biosimilar alternative.
Unfortunately, critics have successfully framed this legislative push as nothing more than brand-name drug manufacturers using the power of law to block generic competition. They say notification would arouse patients’ suspicions and make them nervous to take low-cost biosimilars, causing many to opt for the more expensive brand-name treatments.
Not true. The bill is based in good science. It wouldn’t dictate the treatment protocols of doctors. It wouldn’t constrain the availability of biosimilars. And it wouldn’t dissuade patients from choosing viable low-cost options. All this legislation would do is provide people with the information they need to make good health care decisions.
Unlike chemical pharmaceuticals, biological medicines are constructed from living material. They typically replace or modify the natural activity of substances native to the human body, such as enzymes, hormones or antibodies. As a result, biologics can be considerably more effective than the pills in your medicine cabinet.
These advanced medicines are particularly important in the fight against cancer. By selectively targeting specific aspects of cancer cells, biologics kill fewer healthy cells and minimize toxic side effects. Some even help develop the red and white blood cells critical to a healthy immune system.
At the Global Colon Cancer Alliance, we assist more than 600,000 patients each year through awareness and support programs. So we’re eager to see copycat biologics hit the market.
In the United States, cancer is the cause of nearly a quarter of all deaths. Colon cancer is the second most deadly form. More than 150,000 Americans are diagnosed with the disease annually and more than 50,000 will die from it. Cutting-edge biologics offer those suffering from this and other forms of cancer new treatment options and improved hope for survival — but only if they are administered safely and accurately.
Biologics are so powerful because they are so much more complicated than traditional treatments. The average biologic molecule is about 1,000 times larger than a molecule from a typical chemical drug. Biologics are so profoundly complex that it’s effectively impossible to make an exact duplicate.
A traditional pharmaceutical is produced via a straightforward manufacturing process with clear chemical reactions. Biological drugs, on the other hand, are synthesized under often indeterminate conditions and the precise mechanism of their therapeutic effects is often poorly understood. So, unlike traditional generics, biosimilars are not exact copies of the brand-name drugs they’re based on. There will always be some slight differences.
For most patients, those differences don’t impact the drug’s therapeutic effect. However, for some these structural variations could cause adverse health consequences. The same rules that govern dispensing generic drugs won’t provide sufficient patient safeguards for biosimilars.
This is why the commonsense substitution rules being considered by state leaders make sense. If doctors are promptly and properly informed, they can evolve treatment regimens accordingly if any adverse outcomes arise. It’s all about patient safety.
Biosimilars have enormous potential to improve health and cut costs. The bill now before the Pennsylvania Legislature would establish a basic level of consumer protection without hindering the ability of patients to freely and widely access these drugs. Pennsylvania must pass this critical legislation.
Andrew Spiegel is a co-founder and co-chair of the Global Colon Cancer Alliance (www.global cca.org).