Sonia Oskouei, PharmD, vice president of biosimilars at Cardinal Health, on the results of Cardinal Health’s assessment of the current biosimilars market published in the 2022 Biosimilars Report.
Pharmacy Times interviewed Sonia Oskouei, PharmD, vice president of biosimilars at Cardinal Health, on the data presented in Cardinal Health’s 2022 Biosimilars Report, which predicts 2022 will be a turning point in the adoption of biosimilars in the United States.
Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times. Joining me is Sonia Oskouei, PharmD, vice president of biosimilars at Cardinal Health, who is here to discuss a 2022 Biosimilars Report from Cardinal Health that predicts this year will be a turning point for biosimilars in the US, and specifically insulin biosimilars.
So, why are insulin biosimilars a focus in this report?
Sonia Oskouei: Yeah, this is a big milestone in the biosimilars activity with insulin being approved—and there's a few reasons for it. First being it's the first insulin biosimilar to be approved, which is bringing biosimilar competition to a new therapeutic area of diabetes. It's also the first interchangeable biosimilar to be approved and available in the market, which is a big milestone moment.
We've been talking about interchangeability for several years now. This is also the first biosimilar that's going to be available or is available already to be dispensed at retail pharmacies, and therefore built primarily under the pharmacy benefit. So this is putting retail pharmacists now in an even more empowered position to support biosimilar transitions, adoptions, and even the education process within their communities.
So, because of all this activity, this is a big focus in the report. It gives us a glimpse into how biosimilars will potentially perform more in the pharmacy benefit, which if we look ahead at the pipeline, we're going to have more and more of these products coming that are going to be self-administered.
Alana Hippensteele: Right. What is the FDA’s interchangeability designation and how does it come into play in relation to the findings of this report?
Sonia Oskouei: Sure, so interchangeability designation is a regulatory term, which ultimately enables pharmacist-level substitution per state laws. So you go into a pharmacy with a script with a brand for example, this will give the authority by a pharmacist to substitute to the biosimilar per state law. So much like how we see generics, manage and retail pharmacies.
This comes into play because now that we have our first insulin biosimilars that are spent in retail pharmacies, this puts pharmacists in those positions to help facilitate the transitions. But this is important to dig into because it's almost ironic, we've been talking about interchangeability for really the past 7 years, a lot of education has been discussed around it. A lot of misperceptions are out there around what it needs or what it entails. And you look at our activity—thus far, all the products are majority, the products are those that are under the medical benefit administered by a provider outpatient infused products. So the implications of interchangeability don’t apply as much.
Now this is where the irony part comes in. Now that we have our first interchangeable biosimilar and it's hitting retail pharmacies, there's a lack of familiarity and understanding of what this designation is and what it entails amongst the stakeholder groups that are now managing it. So for example, less than 20% of the participating pharmacists in our surveys were very familiar with interchangeability designation. So this was a big signal that we have a lot of educational efforts needed to help ensure familiarity with this concept.
Alana Hippensteele: What were some key biosimilar milestones in 2021?
Sonia Oskouei: Yeah, so we had our first interchangeable biosimilar approved and launch for the insulin long-acting insulin agent. So very exciting, big milestone event. We also had the second interchangeable biosimilar approved for Boehringer Ingelheim’s [adalimumab-adbm (Cyltezo)] injection, which is a biosimilar to [adalimumab (Humira)] that was anticipated to launch in 2023, along with the other adalimumab biosimilar candidates.
We also had the first ophthalmology biosimilar approved, and this is a biosimilar for ranibizumab. That's expected to launch summer this year around this timeframe. So you're seeing more approvals and activities occurring for products that are going to expand the therapeutic areas, the sites of care, for example, and reach more patients. So exciting milestones in 2021.
We also saw quite a bit of regulatory discussions and congressional efforts around ensuring a healthy competitive US market and bringing lower cost alternatives to market. So 2 of those bills, for example, which are bipartisan, was ensuring or advancing Biosimilar Education Act and the other one was ensuring Innovation Act, again, all aimed at supporting these lower cost alternatives in the market.
Alana Hippensteele: What is some payer coverage trends in therapeutic areas of note outlined in the report?
Sonia Oskouei: Yeah, so this part of the report revealed some strong correlations between payer activity and the adoption rates that we see particularly in oncology. So over the past couple of years, we saw greater coverage of oncology biosimilars, and not just coverage but greater percent of those that are in preferred formulary positions.
So as you saw greater coverage from a payer standpoint, you saw greater adoption of those products. So it makes you see the strong correlation and the fact that managed care stakeholders really do well—the key to accelerating or potentially creating barriers to biosimilar adoption. And we expect that this correlation can continue to get even stronger as we get into the pharmacy benefits space with [pharmacy benefit manager (PBM)] formularies.