What is the extent of misinformation on biosimilars and who is most vulnerable to it? We talked with Dr. Yoon about this and a number of related topics.
Biosimilars Review & Report: What do you believe is the greatest challenge (or challenges) today regarding prescriber and patient comfort with using biosimilars as opposed to originator biologics?
William Yoon, PharmD, MBA: Biosimilars face numerous amounts of challenges in the US that have affected patient access to life-changing medicine. First, we have insufficient education. We have learned from our global experience that successful uptake is centered around a multistakeholder approach. It’s critical that we continue to join forces with government, regulators, payers, healthcare providers, and patients to further educate on the value of biosimilars.
The second major challenge has to be addressing misinformation campaigns. Fortunately, the FDA has recognized there are a number of campaigns that have been initiated by several reference manufacturers; the sole purpose of these campaigns is to spread misinformation. As you know, the FDA is currently working to address this issue.
The third relates to the lack of payment policy incentives to drive biosimilar adoption. The Center for Medicare and Medicaid Services can use several approaches to incentivize biosimilars uptake and savings. We have a team on the Hill who is doing a lot to challenge and knock down the barriers in Part B and Part D. For example, in Medicare Part B, you can have zero dollar co-insurance for patients prescribed biosimilars. On October 1, a bipartisan bill was introduced by Congressmen Peters, King, and Brindisi to eliminate the cost sharing. Another policy incentive could be shared-savings models for physician reimbursement or incentivizing provider reimbursement. In part D, a specialized tier for biosimilars or even the zero-dollar copay like the bill I mentioned could help greatly.
Nonetheless, we all must work together to overcome these barriers and hesitancy to make biosimilars more available. The time for change is right now. We hear a lot about these skyrocketing health care costs. As an organization, Sandoz is committed to biosimilars and ensuring access to these lower-cost options. We were the first to bring a biosimilar to the US and also the first to really have a successful biosimilar story. We have proven biosimilars expand patient access to these life-changing medicines while increasing health care savings and fueling innovation.
BR&R: Let’s delve into the misinformation aspect for a moment. Which groups do you think are most vulnerable to this line of attack? Are patients the only group at risk today, or do physicians still have doubts about biosimilar efficacy and safety?
Yoon: I would say both. Regardless of the source or the communication channel, misinformation around biosimilars is dangerous. It threatens to further forestall the widespread uptake of these valuable medicines. Due to these misinformation campaigns, it’s critical that all stakeholders receive accurate and factual information. The FDA has done a great job providing a Web-based resource for biosimilar education, with videos, fact sheets, infographics, and other materials. They had even developed print ads.
BR&R: To what extent do you think the dissemination of this misinformation on biosimilars sort of mimics what occurred with the initial introduction of generics and generic substitution?
Yoon: Although generic drugs are widely accepted today, there was a significant amount of misinformation in the 1980s about their safety, efficacy, and quality. We’re hearing those same arguments about biosimilars today, in an effort to prevent more people from realizing the potential savings that biosimilars can bring.
Biosimilars approved by the FDA have the same efficacy and safety profile as their reference products. Approved biosimilars have gone through a rigorous development and a testing process. They have the same primary amino-acid sequence, route of administration, the dosage form, and the strength as their reference product. And they demonstrate matching purity, potency, safety, efficacy and immunogenicity
It’s important to develop and share educational tools that are critical to our stakeholders. I firmly believe that a number of stakeholders play a very critical role in this. Number 1 is patient advocacy groups. They play a major role, because they are highly trustedby both newly diagnosed patients and those living with chronic illness. In today’s information age, enabling patient groups to distribute educational materials is critical. These materials have to be accurate, and they have to be easy to understand to be beneficial to all.
Second, I believe that professional societies should continue to develop position statements and white papers with summaries that are accurate.
As I mentioned earlier, the FDA has a wide variety of educational materials for both the healthcare professionals and patients.
In the future, it will be important to incorporate knowledge around biosimilars into the curriculum of pharmacy, medical, and nursing schools. Once the healthcare practitioner understands biosimilars, their approval process, and their promise, these health professionals will become more accepting of these options, andnd better able to educate other folks.
BR&R: That’s a great point. I don’t have any knowledge regarding any schools of pharmacy today who are actually teaching or covering the biosimilarity question.
Yoon: I was invited as an alumni to speak at Purdue’s School of Pharmacy last year. Students’ level of interest in biosimilars was incredible; they had heard of them, but they had little knowledge about them. I don’t know whether other pharmacy schools have added it to their curricula. That’s something we have an investment in. We as manufacturers and payers should definitely promote and sponsor that.
BR&R: Let’s talk about Sandoz’s experience with Zarxio®. As you pointed out earlier the most successful biosimilar story in the four years of availability in the US. It has garnered a considerable share of filgrastim prescriptions since its initial launch in 2015. What do you believe is most responsible for that success?
Yoon: When we launched Zarxio in the US, we reached out to a wide variety of stakeholders across the healthcare continuum to address the barriers to biosimilar adoption. We also enacted a comprehensive medical strategy to reinforce the value of biosimilars overall. We have demonstrated that we saved the US healthcare system about $500 million dollars in less than 2 years and became the first biosimilar to surpass the reference biologic in market share—we’re nearly at 50%.
We now have eight biosimilars approved globally, with more than 10 in the pipeline. We have also learned very valuable lessons that enabled us to bring biosimilars to the US.
There are multiple areas where the US has taken a different approach than the EU, including naming, interchangeability, and requirements for demonstration of analytical similarity. Aside from those different regulations, we continue to face numerous unique challenges in the US that are ultimately affecting patient access to life-saving biological medicines. We’ll continue to stay engaged in discussions about these challenges as well as other biosimilar policies that matter, and continue to help the environment for the development and access to these medicines.
BR&R: In the case of filgrastim, a follow-on medication (Granix®) preceded Zarxio in the marketplace by a couple of years. Do you believe the presence of Granix smoothed the way for folks to start thinking positively about the uptake of this new biosimilar?
Yoon: I would say no. Granix was approved via a completely different pathway as you know (the 351[a] pathway vs 351[k] for Zarxio). Granix is not a biosimilar product, and our challenges atSandoz with being the first to bring biosimilars to the US market were different than those faced by the manufacturer of Granix.
BR&R: My personal opinion is that in 2015, there was likely a good deal of misperception about the molecules and the approval process. The marketplace was in its infancy. My next question is a little more speculative. Sandoz is getting ready to enter into the pegfilgrastim marketplace with a biosimilar within the next few months. What marketing lessons, if any, do you hope to be able to apply with the pegylated biosimilar that you were able to successfully use to market Zarxio?
Yoon: The FDA has not yet taken action on our pegfilgrastim BLA resubmission and the review is still ongoing at the agency. We do remain confident in the quality of our dossier but I can’t comment on our upcoming marketing strategy or our commercial plan.
With that said, we’ll have to overcome several barriers to be successful. I can tell you that from the aspect of tens of thousands of people who undergo chemotherapy, it’s critical to have both the long- and short-acting filgrastim treatment options. Pegfilgrastim is made by adding polyethanolglycol to the filgrastim molecule. It can be attached to the drug molecule through a process we call pegylation. This slows down the elimination. It extends the half-life, so there’s a longer duration of effect.
We’ve already proven that biosimilars can create a massive savings in the US. In the year before the introduction of Zarxio, spending on filgrastim had increased by 4%. After Zarxio’s introduction, spending decreased by 28% through 2017, while the total volume only dropped by 13%.
BR&R: Thank you, William!