Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, foreshadows how the US market introduction of adalimumab biosimilars could influence future biosimilar entrances and discusses why educational efforts need to be tailored to different specialties and stakeholders.
Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars and specialty at Sandoz, foreshadows how the US market introduction of adalimumab biosimilars could influence future biosimilar entrances and discusses why educational efforts need to be tailored to different specialties and stakeholders.
Besides the introduction of adalimumab biosimilars, what are you most looking forward to seeing happen this year for biosimilars?
Oskouei: So, in addition to the exciting adalimumab biosimilars activity this year, I'm really looking forward to just seeing continued growth in the overall US biosimilars market. And so through increasing competition, you can lower costs and generate additional savings opportunities, enhancing patient affordability, and accessibility to these critical biologic treatments. And the financial impact we've had from biosimilars in the US so far has been significant. Since 2015, biosimilars have generated more than $13 billion in health care savings, and latest projections show that savings could exceed $180 billion over the next 5 years, driven by biosimilars. So, by lowering these costs, not only do you enhance patient affordability and accessibility, potentially what you're also doing is creating a channel for additional innovation and new treatments to come to market.
Additionally, what I'm looking forward to this year is also increased experience with biosimilars in some of the more recent therapeutic areas to gain biosimilar treatment options, such as ophthalmology and diabetes. So, naturally with more experience with biosimilars in these areas, you could strengthen clinical confidence and familiarity, which will ultimately position stakeholder groups to best adopt and support potential future biosimilar assets that will be coming out in these therapeutic areas as well.
Lastly, I'll note that I'm excited to see activity that could bring biosimilars to expanded therapeutic areas. For example, the FDA recently accepted Sandoz' BLA [biologics license application] for one of the first, if not the first, denosumab biosimilars in the market. So, this will also expand treatment options with biosimilars not only for the oncology indication, but also in the treatment of premenopausal patients with osteoporosis who may be at increased risk of fractures, as well as patients with treatment-induced bone loss.
What needs to happen to provide better clarity and comfortability on interchangeability in 2023?
Oskouei: As market research continues to indicate, interchangeability still has a lot of associated misperceptions with it, which could lead to misinformation and create biases in decision making when it comes to certain products.
So, we know education is still huge when it comes to interchangeability. And the FDA has done a great job of creating more and more material to tackle this misinformation. It's tailored towards different stakeholder groups, which is very helpful as well. But this material is only as good as it gets used. So, it really needs to be a multistakeholder effort from provider, pharmacies, pharmacists, even patient advocacy groups, and payers, of course, to really come together and tackle this misinformation.
I'll also say that clarity is not only needed with the actual designation or the definition of what it is, but understanding the role of interchangeability in key stakeholder decision making. So, what is the weight or the scale of influence that designation will have on provider prescribing behavior, payer formulary coverage, and even patient acceptance. And this is something we anticipate to come to light even more this year when we have more experience with biosimilars that have the designation on market. And that will allow us to understand more so how significant or not that designation is.
A recent bill was introduced in Congress that seeks to remove the switching study requirement to obtain an interchangeability designation. Additionally, of the 4 interchangeable biosimilars approved, 3 were approved without requiring data from a switching study. Do you think the FDA should remove the requirement, why or why not?
Oskouei: As a reminder, the US is the only country that has interchangeability as a regulatory designation. And ultimately, this allows pharmacists-level substitution per state laws. But part of the big challenge with the designation that remains is again the misperceptions associated with it, which include that it's associated with clinical performance, or even misperceptions on how the FDA grants that designation.
So, at the end of the day, we want to see a healthy competitive market in the US to deliver on the promise of biosimilars for patients around accessibility and affordability. And to do so, it's critical that we continuously seek opportunities to enhance regulatory efficiencies with some of these designations, not just interchangeability, but the overall biosimilar approval process.
And we could tell there's been signals by the FDA that there's appetite to do this, especially with the latest BsUFA III [Biosimilars User Fee Act III] regulatory sciences pilot program. So, that program has 2 aims and they're called demonstration projects. The first one is to advance the development of interchangeable products, which includes the use of additional data sources like real-world evidence, and the second aim is to improve the efficiency of biosimilar product development. So, I believe there's going to be ongoing efforts around this topic to tackle some of the key challenges around the designation and beyond.
Several reports have noted a growing increase in familiarity and confidence in biosimilars among rheumatologists. Now that we’re starting to have adalimumab biosimilars, why have these increases occurred and what can be done to achieve similar patterns in other new areas of the industry, such as ophthalmology?
Oskouei: The growth in familiarity and confidence in the rheumatology space in particular could also be attributed to just the time of biosimilars on the market with some of the other agents, specifically the infliximab biosimilars.
So, by having more exposure and use of these products from the various stakeholders, you naturally have increasing growth, comfort, and confidence as recent market research has shown as well. I also think the preparation for this big year, with the adalimumab biosimilars, which is probably the most significant pharmaceutical events to happen in US history, also stimulated the increase in attention and awareness to biosimilars amongst immunology providers and stakeholders.
But the key part when it comes to the familiarity in education when we go into different therapeutic areas is that we don't want to start from scratch every time we have a biosimilar for the first time in a different therapeutic area. So, of course, we want to leverage experiences and real-world evidence that we see associated with biosimilars in other therapeutic areas, but we know each one has its unique needs.
And part of that, for example, as we look at the neurology space, we have a very highly motivated and activated patient population when it comes to neurology and making shared decisions with their providers. So, for example, in that one, the patient population is really key to engage when it comes to education on biosimilars, maybe uniquely so compared to some of the other areas. It's important to know that it's not a one size fits all approach when it comes to tackling education and making sure we're prepared for biosimilars in the future. So, it's very important that we look at each biosimilar product and therapeutic area almost independently to understand the market landscape around each one.
Optum Rx, Express Scripts, and Prime Therapeutics have announced that they will cover some adalimumab biosimilars at parity with originator Humira. How do you think this decision will influence the formulary decisions of other pharmacy benefit managers regarding adalimumab coverage?
Oskouei: Well, this is the key question for many stakeholders, especially given the significant influence the managed care landscape has on biosimilar adoption in the US. So, I'll say that time will tell but not too much time because we are now here in the milestone year of 2023.
But we do know that biosimilar activity in addition to the other promised benefits associated with these products, we know that essentially fueled greater insights into the US health care delivery model which continues to generate debate and further increases vulnerability to the call for action that we see for tackling misaligned incentives that may exist.