Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: The education piece with healthcare professionals, with team members, will a long-standing case. We have some key points to address over the next 5 years, leaving us to biosimilars 102. When it comes to curative therapy—not supportive care but curative therapy—it will be the fact that we have to address the outcomes of clinical trials and safety and efficacy, really detailing the lack of difference. Not the difference, but the lack of differences among these biologic agents. Taking a look at their original product or brand-name product and the biosimilar, we’re really moving to how that drug was approved, what are the pieces to improve that drug. That’s our key mainstay for discussion.
Looking at other pieces, we’ll be including what those indications are, addressing how to look at the EMR [electronic medical record] system as well, how to integrate those pieces, and also the discussion on clinical trials. Those are just a few of the touch points we need to make across the board for biosimilar education.
We’ll also need to take a look at variations on discussion interchangeability—how that comes across, because different institutions may have recognition of something called therapeutic interchange, versus that of biosimilar-based limitation. We’ll also have to address how to look at biosimilar switching within institution. Do we need to have guidelines, pathways, discussions as well? Other points of contention, of course, will be payer-based differences. How do you address that from one biosimilar to a biologic across a board and where you have a large amount of payers, too.
Kashyap Patel, MD: There are some challenges that can be solved by increasing awareness. Biosimilars can sponsor the education program at the national meetings, whether it’s COA [Community Oncology Alliance], ASCO [American Society of Clinical Oncology], ACCC [Association of Community Cancer Centers], or multiple not-for-profit associations that sell the purpose of bringing awareness about the options of treatment. The biosimilar manufacturers should really make a significant effort to put in resources, so physicians who are on the sidelines can become aware of the biosimilars. They can also go to patient advocacy groups, as well as midlevels, ONS [Oncology Nursing Society], or nursing NP [nurse practitioner] societies to bring education and resources for biosimilar awareness.
My closing remark of biosimilars is I’ve been in the healthcare field for the last 20 years in America. And for the last 20 years, we’ve been struggling with the issue of drug price. Biosimilars offer really almost all the important aspects of healthcare to address drug prices. They can improve the access, making drugs more affordable. And biosimilars are not confined to oncology. They’re also in the autoimmune space. Biologic compounds affect every aspect of human life as long as we live. Europe has done pretty good job of assimilating biosimilars since 2006. They have administered over 700 million unique doses without any difference in outcome or any adverse reactions. I think our country should adopt and implement biosimilars without any inhibitions.
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: The educational topic for biosimilars will probably be within the next 5 to 7 years. We had a large, robust amount of knowledge in many therapeutic indications. When it comes to the understanding of biosimilars, we’re still in biosimilars 101, your freshman class of biosimilars.
We’re now moving to therapeutic indications. This is going to be an indication where we’re going to go with curative-based therapies. In terms of cancer, those become critical, because questions arise and adverse-affect profiles vary based on the physician’s use in an anecdotal manner. Also detailing or removing that fear of using biosimilars is needed.
How do you do that? You need to educate the team members on the data, how the actual clinical trials perform. In addition, there need to be a large amount of data or evaluation on addressing the biosimilar approval process. Because many people think that the same path didn’t occur for their product. Yet all those variation, post-translational modifications, cell-line changes over the years—which we’ve known about for decades—and the actual bench-based sciences are occurring with the biologic. A discussion on drift, post-translational modifications, all are very well known. When it comes to the biosimilar, all of a sudden it becomes, “Oh, my gosh, I was unaware of that.” That education needs to be put forth.
But also dimensions on education for implementation, for understanding those people who are not in direct patient care contact with our finance team members, our pharmacists or our team members, all are very important. In fact, even the people who are working on the payer side need to address these points as well.
I think we have a large amount of understanding that needs to go on. Even more so when it comes to rheumatology and endocrinology. For example, diabetes. These are also very important areas for addressing these patient populations.
Kashyap Patel, MD: I’m a little concerned about the manufacturers of the biosimilars for not having enough time, resources, and efforts in educating biosimilars. If you go back and look at the first biosimilar that was approved in the autoimmune space, infliximab, the market uptake was only 2% because most of the stakeholders—which included GI [gastrointestinal] doctors, patients, nurses, and pharmacists—had no idea what a biosimilar was.
For anyone now, that’s a big stumbling block in acceptance of the biosimilars across all the sectors. Manufacturers have to make a better effort in improving awareness, education for the payers, physicians, midlevels, nurses, pharmacists, and patients.