Unbranded Biologics: An Overview - Episode 1

Overview and Prevalence of Biologics

Dr David Charles, MD, opens a discussion surrounding the increasing usage and unique characteristics of biologics.

David Charles, MD: Hello, I’m David Charles. I serve as professor and vice chair of neurology at Vanderbilt University in Nashville, Tennessee, and chief medical officer of the Alliance for Patient Access. Thank you so much for the opportunity to join you. Please note that I’ll be sharing my opinions but not representing my academic medical center or the Alliance for Patient Access.

What makes biologics a priority for payers is that biologics are expensive medications. Medication spending has been a focus of health care policy in the United States for many years. It’s an intense area of focus because resources for health care expenditures are limited. Biologics are getting a lot of attention primarily because they’re amazing therapies, but they’re a priority for payers because of the overall expense as well.

When thinking about biologics, one of the most important things to do is first compare it with what we think of as a traditional medication that we might pick up at the pharmacy. Most traditional medications, such as a tablet, like I take for hypertension, are small-molecule medications that, compared with biologics, are relatively simple to create, replicate, and produce for mass marketing to be available to patients.

Biologics, on the other hand, are derived from living sources. Sometimes that can be tissue or cells. They’re very large, complex, and often protein molecules that are very difficult to manufacture compared with a small-molecule pharmaceutical. Therein lies the increased cost that comes with the manufacturing process. Biologics in some cases can be very delicate in regard to the handling of the biologic and how it’s prepared, shipped, transported, and ultimately delivered to the patient. In some cases, extreme care has to be taken with temperature monitoring to ensure that the final product the patient receives is safe and effective.

The evolution of biologics over time is quite interesting. We’ve had biologics around for years. Definitions of biologics would include things like insulin and vaccines, but today when physicians and patients and policymakers think of biologics, they’re thinking about the biologics that are being developed to treat conditions like cancer, dermatologic conditions, and multiple sclerosis.

Over time, the introduction of these new biologics and biosimilars has been a remarkable advance for medicine. In the field I’m in—neurology—when I began training for multiple sclerosis, which would affect people typically in the midportion of their life—in the prime of life with young children at home and so forth—we had 2 treatments: physical therapy and steroids. Patients had relentless progression and advancing disability, often leading to death. With the advance of biologics, we now have so many medications and biologics to treat multiple sclerosis. The horizon is completely different for a newly diagnosed patient today. Now it’s a manageable condition compared with someone who was diagnosed in the early 1990s.

Transcript edited for clarity.