Clinical Advances and Challenges With Biosimilars - Episode 1
Bruce A. Feinberg, DO: Hello. Thank you for joining The Center for Biosimilars™ Peer Exchange® titled “Clinical Advances and Challenges with Biosimilars.” The biologics drug industry has seen a significant growth in recent years, both in terms of the drug pipeline and FDA approvals. Prescription drug spending is high with biologics. However, branded biologics worth more than $70 billion will come off patent by 2018, and the RAND Corporation predicts that infusing market competition with biosimilars can reduce direct spending on biologics by $44.2 billion from 2014 to 2024. At the time of this filming, 5 biosimilar products for inflammatory diseases and oncology have been FDA approved. Today’s discussion will focus on some of the practice challenges faced by care providers as they navigate the use of these follow-on products in the clinic.
I am Dr Bruce Feinberg, and I’m vice president and chief medical officer at Cardinal Health Specialty Solutions in Dublin, Ohio. Participating today on our distinguished panel are: Dr Hope Rugo, professor of medicine, director of Breast Oncology Clinical Trials and Education, and a breast cancer specialist at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, California; Dr Brandon Shank, a clinical pharmacy specialist in Houston, Texas; and Dr Marcus Snow, rheumatologist and director of the Scleroderma Clinic at the University of Nebraska Medical Center in Omaha, Nebraska.
Thank you so much for joining us. Let’s begin. Marcus, I think I want to start with you because the biosimilar experience is somewhat limited in this country.
Marcus H. Snow, MD: Yes.
Bruce A. Feinberg, DO: But, there is experience overseas. Across the pond, throughout Europe, there is experience now with a half-dozen different biosimilar drugs, most in rheumatology, and the rates of adoption have been very different. What is that, as far as you know—the patient experience, the provider experience—and why are those rates of adoption so different?
Marcus H. Snow, MD: Most likely, the rates of adoption are very different because we have a different healthcare system. In Norway, it is basically a single-payer system. When infliximab went off patent and there was a biosimilar available, the government was able to negotiate, essentially carte blanche, that the new infliximab was a biosimilar. And so, you see extreme differences in rates of adoption due to that.
Bruce A. Feinberg, DO: And we’ve seen as high as about 70% market share in Europe? And more 10% to 30% in other markets—France, Germany, and others?
Marcus H. Snow, MD: Yes.
Bruce A. Feinberg, DO: Are there any lessons for us? Are there any learnings that we can take? Is it going to be, really, insurance—whether government or commercial payer determined adoption—because of formularies, step edits, and other mechanisms that will likely be in place in rheumatology? Will that drive it, rather than it being patient or physician directed?
Marcus H. Snow, MD: Yes. I think this is going to be driven by formularies in the United States. In Europe, it has been driven by a single-payer system, or the government has been changing those contracts. That’s what we’ve seen. We can learn amazing amounts from the Norway experience and the NOR-SWITCH trial, which showed that multiple indications when switching infliximab to a biosimilar had noninferiority. And so, the lessons we can learn will help us in the United States as we try to figure out how these medications fit into our armamentarium and how they fit into formularies.
Bruce A. Feinberg, DO: Brandon, as a pharmacist in a large institution in Houston, you had the opportunity to experience the first, I would say, oncology-related biosimilar. That is the biosimilar to the reference brand for G-CSF (granulocyte-colony stimulating factor)—Neupogen. I’m curious to hear if, as an institution, they’ve adopted that product?
Brandon Shank, PharmD, MPH, BCOP: Currently, we keep that reference product as our formulary. However, some patients’ insurances for outpatient administration do require the use of a biosimilar. In those situations, we have switched patients. But, our current formulary status and all of our order sets and designs just currently include the reference product, Neupogen.