Susan G. Komen®, the world’s leading breast cancer organization, is seeking to educate patients about a new wave of alternative drugs, known as biosimilars, that will soon hit the market to treat HER2-positive breast cancer.
“The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25 percent of all breast cancers. As patient advocates, we are working to ensure that patients are educated about biosimilars and can feel comforted that they are F.D.A. approved and just as safe and effective as the original biologic drug,” said Paula Schneider, CEO of Susan G. Komen.
Biosimilars are drugs that are “highly similar” to an existing biologic drug, which are at the forefront of the latest targeted therapies. Biologics are powerful and complex drugs made from biological products like antibodies or proteins and can come from all sorts of living sources – animals, plants and even bacteria. While biologics, like vaccines and insulin, have been around for many years, the number of these drugs has vastly increased since the 1990s and are now making it possible to treat some illnesses more effectively.
The most commonly-prescribed biologic to treat HER2-positive breast cancer is trastuzumab, also known by its brand name Herceptin. Developed in the 1990s, Herceptin attaches to the HER2 protein on the surface of the cancer cell which slows or stops the cancer cell from growing. The Federal Drug Administration (FDA) has approved several biosimilars for trastuzumab, which will likely become available soon. Here are the four things patients need to know about biosimilars:
- Biosimilars are NOT generic drugs, but they are close.
Generic drugs are identical copies of chemicals used to make up a drug, like ibuprofen, for example. Biosimilars, on the other hand, are “highly similar” to the original biologic. Since they are made up of living things, biologics are highly complex and are impossible to exactly replicate. However, these small differences don’t affect how their biosimilars work.
- Biosimilars are just as safe and effective as the original biologic drug.
Biosimilars must be approved by the FDA, and do not have any “clinically meaningful” differences in safety, purity and potency – or strength – from the original biologic drug.
- Biosimilars will provide more treatment options.
The availability of biosimilars may provide doctors and medical facilities with more options because there may now be more than one drug to choose from. Patients should talk with their doctor about what treatment option is best.
- Biosimilars should help reduce overall health care costs.
Biosimilars are slightly less expensive than the original biologic drug, although the costs are still high due to the complex manufacturing process required. As more biosimilars enter the market, competition may bring costs down over time. For now, however, it is unclear how their use will directly impact patients’ costs.
To learn more about biosimilars, visit komen.org