Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products, said a panelist at the National Policy and Advocacy Summit on Biologics.

In the United States, some physicians and patients remain wary of using biosimilars, even though the FDA certifies them as equivalent to originators on safety and clinical efficacy. Because they are made from living organisms, biologics—whether reference drugs or biosimilars—may differ slightly from one manufactured batch to another, but strict process controls keep these differences within tight margins of allowed variation.

Panelist Jeffrey VanDeusen, MD, PhD, explained that these subtle differences can actually be an asset in treating certain patients. “Instead of perhaps 1 therapy that is able to target a pathway, we've got multiple medications that are different enough that if a patient may be allergic to that medicine, now we have different options to offer that patient.”

VanDeusen, medical director of the James Cancer Network and an assistant professor of medicine at the Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute, gave an example of one of his current patients with cancer who developed an allergy to originator trastuzumab (Herceptin) and was able to continue treatment using a biosimilar.

“Ten years ago, I would have had to stop the medication for her. Now, I can continue that medicine….I can effectively continue to control her disease without relying on new or different medicines,” he said.

Value of Biologics

VanDeusen discussed other ways biologics have improved treatment options in the oncology space. He said that biologics, especially growth factors, have extended the lives of patients much longer than before.

“We are able to target specific proteins in cancer cells or pathways in cancer cells, and this has allowed us to either control or even completely eliminate cancers, whereas before, we would just have drugs that would perhaps delay the growth for a while. Now, instead of weeks to months, we can change that to years or even a normal lifespan,” said VanDeusen.

Further, “as we get more and more sophisticated in our understanding of the immune system and how to help it defeat cancer, we are going to see biologics play a larger role as these agents are used in that in that type of fight.”

Diagnostics Issues and Treatment Delays

During the panel, VanDeusen mentioned that delays in diagnostic testing, with genomic sequencing or proteomics, could prevent patients from receiving a biologic treatment in a timely fashion. Without diagnostic testing, which can be expensive, physicians are not able to prescribe biologic treatments.

“For oncologists, when a procedure is done as a diagnostic test—for example, a liver biopsy—often there is a 2-week cool-off period, where we have to wait before additional testing can be ordered on the specimen. And in that time, the patient’s disease can grow. And that is hard for both the oncologist and the patient,” said VanDeusen.

Additionally, VanDeusen said that a lack of health coverage can delay diagnostic sequencing even further to where the patient’s symptoms may worsen, allowing the cancer to spread. In some cases, he said, delays may allow a patient’s disease to worsen to the point that therapy is no longer an option.

The National Policy and Advocacy Summit on Biologics was a virtual conference on November 18, 2020, hosted by Biologics Prescribers Collaborative, the Institute for Patient Access, and the Alliance for Patient Access.