Fresh from Organon sharing its results for the third quarter of the 2024 fiscal year, the firm’s US Biosimilar Unit Lead Jon Martin spoke with Generics Bulletin about the company’s performance and upcoming plans in the space.
Following a previous update earlier this year, Martin has now shed further light on the performance of Organon’s Humira (adalimumab) biosimilar Hadlima, as well as the next steps with the Prolia/Xgeva (denosumab) biosimilar HLX14, which is now under evaluation by the US Food and Drug Administration.
Third-Quarter Results Set Course For The Near Future
Looking at the company’s third quarter results, Martin pointed towards the biosimilars segment’s continued growth in the US where Organon followed its strategy in the next phase of Hadlima’s rollout.
“We continue to show enterprise wide upwards of 16%-17% growth of biosimilars year over year, which in terms of the biosimilar business is quite positive. The US [has] led a lot of that growth, predominantly coming out of the launch of Hadlima where we continue to see uptake on a month over month basis,” he said.
Martin continued with describing the firm’s US Hadlima strategy. “In terms of total prescriptions, the base of our business is built on the Veterans Affairs win,” he stated.
In February, Organon announced that Hadlima was exclusively selected by the US Department of Veterans Affairs as a replacement for Humira on its national formulary.
“We were able to successfully convert 98%-99% of that business within a few months,” Martin indicated. “It just demonstrates the receptivity that the market has to this profile.“
Looking at Organon’s near future, biosimilars are set to be at the center of the firm’s continued growth.
“One of the things you will see is that the biosimilar business has been a key contributor of the growth profile of Organon. Since we’ve spun [out of MSD] , we’ve demonstrated double-digit growth year over year over year,” said Martin.
With that in mind, the company splits its priorities for biosimilars into three pillars.
“One of the priorities is our commitment to ensure that we create a sustainable market for biosimilars. And that’s focused on some state and federal policies about how do we better align incentives and opportunities for patients to save [money] using biosimilars, which would support the adoption of lower price products like biosimilars. That’s the first pillar.”
“The second pillar is we’ll be in our second full year for the launch of Hadlima and we’ll continue to demonstrate growth with our biosimilar. We’ve been successful in terms of our product positioning in terms of the total growth quarter over quarter. And we will remain committed to keeping Hadlima on a growth trajectory.”
Lastly, the firm’s final priority is to focus on its HLX14 Prolia/Xgeva rival. “We are excited that the FDA has accepted our file for HLX14,” Martin enthused. “Our partner [Henlius] is making good progress, and we think that the launch of the denosumab asset fits nicely with our business.”
Ensuring Hadlima’s Continued Success
Organon has previously been vocal in maintaining appropriate expectations of Hadlima’s launch in the US in the face of excitement surrounding the entry of Humira biosimilars in the country.
“We were one of the companies that were indicating that would be a bit of a slower ramp,” Martin recalled. “We understood that 2023 was going to be a year of formulary listing. In 2024, we would start to see some market formation and market formation. And then in 2025 and 2026 we would really see the real ramp up.”
According to Martin, Organon’s expectations mostly played out, which also partly highlights the company’s strategy used in Hadlima’s rollout. “That’s largely played out consistent with what we were signalling. Our pricing strategy was on a market segment focused on a low net cost profile, [which was] agnostic to rebate.”
“If you could do it with rebate, that was fine. If you didn’t need a rebate, that was fine too. And what we realized is there was a decent sized market segment that was out there that was looking for just low-cost products. And we were able to wedge our way into the marketplace with our pricing strategy and the product profile, which gave us a unique position,” he added.
“And so we’ve been able to continue that trend. And on a month over month, quarter over quarter basis, our trend is continuing, and it’s been linear in terms of the uptake. We’ve seen a certain growth pattern in 2024. We expect a very similar growth pattern in 2025, and we believe there could be additional formulary disruption in the latter half of 2025 and early 2026. We think we’re well positioned to when that disruption is to occur,” he suggested.
Regarding Hadlima’s success, Martin pointed to the firm’s strategy with offering both high- and low-concentration formulations coupled with real-world data.
“It is critically important for us to defend our unique product position. We are one of the only companies that chose a single low-WAC [whole sale acquisition cost] strategy. We are one of the only companies that has both a high-concentration, low-concentration formulation. We are one of the few companies that has an evidence package with real-world evidence, with [Hadlima] being tried in a bunch of markets outside of US,” he explained.
Martin said this “product positioning is important because some of the formulary decisions are made based on the current utilization in a market…[based on a] receptivity by the provider prescriber universe. And so when you look to our success where we have had formulary position, we tend to achieve more than our fair share in terms of prescription.
Eyes On HLX11 And HLX14
Looking beyond Hadlima, the company is excited about the potential approval of its Prolia/Xgeva biosimilar. In October, the FDA accepted the company’s application for the denosumab biosimilar, paving the way for a potential verdict and even a launch next year.
“From a planning perspective, sometime in the latter half of 2025, we’re actually planning to launch, and we expect the market to be quite competitive and quite crowded...crowded meaning more than five players in a marketplace,” he indicated.
To bolster its position, the company aims to harness its experience with biosimilars to establish a favorable position in this competitive market. “We have built capabilities that we can bring to market to support the launch of HLX14. We see significant overlap with our current customer base. That’s important for us because the perception of the organization commercializing these products is often part of the product value prop. “
According to Martin, Organon’s presence in the women’s health field could also play a role in keeping a positive relationship with its potential customers. “Organon’s core mission is focused on women’s health…When decisions are made on which product to choose when prices are similar, you start to look at a company’s reputation, ability and understanding of the market. We think the women’s health dimension can be a real differentiator for us.”
Additionally, the company is also settings its sights on the development and possible approval of its Perjeta (pertuzumab) biosimilar HLX11. While the product still has a few years before its eventual arrival to market, Martin sees multiple overlaps between the Perjeta biosimilar and other compounds in its portfolio.
“The positioning for HLX11 reflects a lot of what I said about HLX14. HLX11’s approval will likely be in the latter half of the decade…and HLX11 is highly overlapping with parts of our portfolio. We have a trastuzumab biosimilar [sold as Ontruzant], and there are some overlapping customers that will be important for us. We will have built this relationship and capabilities that will help us commercialize HLX14,” he explained.
Organon added both HLX11 and HLX14 to its portfolio through a $100m+ deal with the Chinese firm Shanghai Henlius Biotech in June 2022. The deal granted Organon rights outside of the US to the two biosimilars, with a further option to gain rights to a Yervoy (ipilimumab) biosimilar HLX13.
Importantly, Organon’s presence in women’s health again comes to the front. “If you think about having a product that is used to treat breast cancer from an organization that’s focused on women’s health, we think it is another important attribute for some of the decisions that could go on. And with HLX11 and HLX14, both diseases predominantly affect women and having the commercialization coming from a women’s health organization, we think helps differentiate,” he highlighted.
Martin describes Organon’s experience with Hadlima and the development of HLX11 and HLX14 as the second phase of development of the biosimilars market. “The first phase of the biosimilars market was that first set of anti-neoplastic, the oncology supportive therapies and even infliximab where we saw the beginning of the launches... and what we’re characterizing as phase two, that’s kind of our HLX products and our Hadlima.”
And looking at the third phase, the company is eyeing further opportunities towards the turn of the decade.
“As we look to the future, immunotherapy, oncolytics and other products are in the 2028-2029 timeframe. And we see that there’s a significant opportunity for companies that are commercializing biosimilars in the years [to come].”
