Knowledge Gaps With Biosimilars

Peter L. Salgo, MD: Hello, and thank you for joining this The Center for Biosimilars^™ Peer Exchange^® titled “Clinician and Managed Care Insights on Biosimilars for Inflammatory Diseases.” Biologic products constitute less than 1% of all prescriptions dispensed in the United States, but they account for more than one-fourth of all US prescription spending. Today’s panel of experts for this The Center for Biosimilars^™ Peer Exchange^® is going to provide an overview of biosimilars, clinician and patient understanding of the biologics landscape, and access considerations. We are also going to focus on a discussion of newly approved biosimilars for inflammatory diseases and how they may change the landscape for treating these diseases from a clinical and from a cost perspective.

I am Dr Peter Salgo. I’m a professor of medicine and anesthesiology at Columbia University College of Physicians and Surgeons. I’m associate director of Surgical Intensive Care at New York—Presbyterian Hospital.

Participating with me today on our distinguished panel are Dr Allan Gibofsky, professor of medicine for Healthcare Policy and Research at Weill Medical College of Cornell University and attending rheumatologist at the Hospital for Special Surgery in New York, New York; Dr Gary Lichtenstein, professor of medicine and director of the Inflammatory Bowel Disease Center at the Hospital of the University of Pennsylvania Health System, in Philadelphia, Pennsylvania; Dr Cole Wilson, assistant vice president of Outpatient Pharmacy Services at the Carolinas Health Care System; and Dr Vibeke Strand, biopharmaceutical consultant and adjunct clinical professor [in] the Division of Immunology/Rheumatology at the Stanford University School of Medicine, in Stanford, California. I want to thank all of you for being here today.

Let’s get right to the point: biosimilars; biologics. Why don’t we discuss some of the gaps in knowledge and common misunderstandings here related to biosimilars among medical professionals and patients? First of all, what are biosimilars?

Allan Gibofsky, MD: Biosimilars are biologically active agents that are similar to biologics. They take their name as derived from that concept. They’re neither better than nor worse than the agents which they were manufactured to replicate.

Peter L. Salgo, MD: We’re talking about biosimilars now, and there’s a syntactic distinction which reflects a real distinction between biosimilar drugs and, then, plain generics for small chemicals. What’s the difference here?

Vibeke Strand, MD: Biosimilars were manufactured based on knowing the primary structure of the reference product without any other knowledge. And so, they’ve been reverse engineered. And that kind of knowledge has developed because of the 20 to 30 years of expertise in manufacturing biologics. So, this is a whole new idea where you start off with, simply, 1 piece of information, and you make the entire product to be highly similar to the reference.

Peter L. Salgo, MD: Highly similar but not necessarily identical.

Vibeke Strand, MD: Correct.

Peter L. Salgo, MD: In 2014, there was a survey that revealed that biosimilars for rheumatoid arthritis were in the pipeline, but rheumatologists were unaware that they were in the pipeline. Why this disconnect? Why don’t people know that they’re coming or that they were coming?

Allan Gibofsky, MD: Well, I’m sure that was true in 2014, but a lot has changed since then. I think it would be very difficult to find a rheumatologist today who hasn’t heard the term “biosimilar.” Indeed, just this morning before coming to the studio, I got an e-mail from the American College of Rheumatology about their new Biosimilars Awareness Education Program. So, I think rheumatologists are aware of it (largely because the initial approvals were in rheumatology). I can’t speak to the awareness in gastroenterology and dermatology, which are the specialties which they use these products in. Gary, what’s your experience?

Gary R. Lichtenstein, MD: I can certainly speak to that. There’s certainly a heightened awareness at this point in time. Back in 2014, there was very little knowledge regarding that. The American College of Gastroenterology, the American Gastroenterological Association, the Crohn’s and Colitis Foundation, and a host of other different representative organizations have put out awareness educational programs, and, I think, the big issue that will face us is that of education.

Peter L. Salgo, MD: Back in April, a month prior to this broadcast, 2 drugs were approved—we’re talking about Inflectra and Renflexis. Are physicians aware that these drugs are now approved and they’re coming to availability? Do people know this?

Allan Gibofsky, MD: I think they’re learning that they’re approved and coming to availability. I think the fact is that there’s a gap between when the FDA takes a regulatory action and when the drug finally becomes available—a gap that can be at least 6 months and maybe even longer. So, the knowledge base is building out there, but there are still some misunderstandings that have to be corrected. For example, at some of the arthritis advisory committee panels last year, we heard people talking about additions to our therapeutic armamentarium—more drugs for patients. And, in fact, these are additional drugs, but they are additional versions of existing drugs.