Over the past year, tremendous strides have been made to create new biosimilar medical products—also known as biosimilars—providing advanced care that’s more readily available and more affordable. So what exactly are biosimilars?
We know that too often we explain cancer care in terminology that just flies right over most people’s heads. That’s why we’re taking a few minutes today to break down what this advancement is and what it may mean for cancer patients.
What Are Biosimilars?
Biosimilars are biological medical products that are highly similar to—and with no clinically meaningful differences from—an existing FDA-approved reference medication or therapy.
Basically, a copy of an existed and approved treatment option.
The product may be produced through biotechnology in a living system, such as a microorganism, plant cell or an animal cell.
How Are Biosimilars Approved?
To receive approval for a biosimilar from the Center for Drug Evaluation and Research (CDER), a manufacturer must demonstrate that the product is highly similar to the reference product in purity, chemical identity and bioactivity. Minor differences in the clinically inactive components are acceptable.
Manufacturers use state-of-the-art comparative tests, along with other information, to prove their case to CDER.
Are BioSimilars & Generics the Same?
No. They’re often confused for each other, but they’re different.
Generic medications are copies of synthetic, man-made medications. Biosimilars, on the other hand, are modeled after medications that use living organisms as ingredients.
It’s also important to note that while generics are an exact copy of an existing synthetic medication, biosimilars aren’t copies—they’re “highly similar” and accomplish the same therapeutic and clinical results.
How Do Biosimilars Benefit Patients?
In 2019, as in previous years, the CDER approved ten new biosimilars. This growing influx of highly similar, highly effective treatments will help create more competition.
That translates to lowering medical expenses by $54 billion over 10 years, or about 3 percent of total estimated biologic spending, with a lower to upper bound range of $25 billion to $125 billion.
Even more important are the benefits for individuals—the mothers, fathers, grandparents and children who are battling cancer.
As more of these treatments become more widely available and affordable, patients will have greater access to the critical treatments they need to beat a variety of cancers, including breast cancer, metastatic stomach cancer, metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
The Kirkland Cancer Center is committed to advancing care for patients diagnosed with cancer. This includes providing comprehensive services to diagnose, treat, and otherwise care for those faced with cancer.