Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars

Transcript

Another aspect expected to influence market adoption is the option for a high-concentration formulation, which currently accounts for 80% of Humira prescriptions in the United States. Does Coherus plan to invest in creating a high-concentration formulation of Yusimry or is it waiting to see how the market develops first?

Reider: We are pursuing a high-concentration presentation, and we will expect to launch that with both our prefilled syringe and auto-injector formats sometime after launch. So, we will be launching with the lower-concentration formulation but with the nonstinging, citrate-free 29-gauge needle.

What's interesting about this—I know there's a lot of discussion around the importance of high concentration—when AbbVie [the maker of Humira] launched the citrate-free formulation, they also launched it with the high concentration. That's really what occurred in that market event, was both of those combined. So, from a purely injection-time standpoint, there's really not much of a difference between the injection time of a low and a high, not really clinically meaningful, but it's really what precipitated the adoption of the current Humira presentation, the combination of the citrate free and the high concentration. But at the end of the day, we're gonna bring that high-concentration Yusimry to market post launch.

We haven't disclosed publicly the status of that program. I'd say just keep an ear out for some of the future investor meetings or earnings calls where we will report on that in due time, but as of now, we haven't publicly stated where that program is in development.

Obviously, as we've been engaging with retinal specialists, their understanding about biosimilars is fairly low right now. And I think that was confirmed in the Cardinal [Health] biosimilar survey, where they interviewed just under 100 retinal specialists and over 80% said that really to get them more comfortable in using biosimilars in the retina space, they would like more education around the biosimilars in the retina category.

So, we launched, in May at the Retinal World Congress, The Promise of Biosimilars disease state education program. And we've had that program now in the marketplace, we had it at the American Society of Retinal Specialists, and it will be at the American Academy of Ophthalmology meeting. This is really a disease state biosimilar education initiative that's really focused to the retinal specialist community, that educates them across the board for the regulatory pathway to how the products are approved, how the FDA designates them with one goal, and that's to educate retinal specialists in the retinal community about biosimilars. So, they have the highest degree of understanding and comfort level so when the products are available, they can feel very good about adopting them quickly.

We're going to continue to advance that initiative, even through the launch of Cimerli that we will bring in early October, because, again "rising tide lifts all boats." So, if we get as many retinal specialists comfortable with biosimilars, that'll enhance adoption. It's the promise of biosimilars program that we've launched.

Udenyca was the second pegfilgrastim biosimilar to be approved by the FDA. Since then, 3 more have joined the pack. How is Udenyca faring in the face of new competition and how has Coherus’ strategy regarding the pegfilgrastim space evolved since launching the product?

Reider: Udenyca, it's a success story. With the second quarter earnings report that we just had, Udenyca has delivered about $1.3 billion in net revenue to the company, our first and only marketed product right now. So, it's been a resounding success in a very competitive marketplace, which is that pegfilgrastim market.

When we launched it back in 2019, we had quickly eclipsed 20% market share, until the COVID-19 pandemic hit in early 2020. And that was really a sentinel event, because, as I was talking about differentiation of products earlier, this is a perfect example, where the innovator had the Neulasta Onpro device [on-body injector for reference pegfilgrastim. And so, with COVID-19, when you're trying to keep people out of the hospital or out of the clinic, it had a differentiated device. As COVID-19 had persisted over these last few years, there really became an entrenched customer preference for it.

Of course, Amgen has competed very aggressively on pricing. And so Onpro retains 46% of the market, and that represents a massive opportunity for Coherus because we intend to bring our own Udneyca on-body device to the market. What we've stated is we expect to launch that in 2023 but we won't be disclosing publicly any of the details of the regulatory filings. But we believe that will open up the next wave of market share growth for Udenyca.

Today, we've finished second quarter at 15% market share in the overall market, which has been declining over the last several quarters because of really significant price discounting from other newly launched biosimilars. We have stated that we're taking a long-term view with our strategy for Udneyca because we have our own on-body device coming. So, we're balancing market share and price trade-offs so that we can preserve as favorable of a pricing position when we bring our on-body [injector] because a lower price today means a lower reimbursement tomorrow.

Some of the other biosimilars that have been taking market share in this category have really more of a short-term view. Come in, drop price, get as much share [as you can]. But as we've seen in products like Sandoz' Ziextenzo with a 35% reduction in their [average sales price] over the last 2 quarters, it's really hard to sustain that kind of strategy. So, we're taking a longer-term view because we've got our on-body device coming and we want access to that $1 billion, 46% Onpro [market] in 2023.