Organon Expects 2028 ‘Tidal Wave’ For Biosimilars

Biosimilars will enjoy a “tidal wave” of competition in 2028, Organon CEO Kevin Ali anticipates, with launches of rivals to Opdivo (nivolumab) and Keytruda (pembrolizumab) coming after the firm introduces planned biosimilars to Perjeta (pertuzumab) and Prolia/Xgeva (denosumab) in the intervening years.

Speaking at the J.P. Morgan Annual Healthcare Conference in early January, Ali acknowledged that in 2023, “the big group of competition was really focused on the Humira (adalimuab) loss of exclusivity event. And then the next tidal wave will come in 2028 with Opdivo and Keytruda.”

“I do believe that 2028 will be another very serious milestone,” he set out, “in terms of a lot of activity around the IOs [immuno-oncology products].” And between now and 2028, there were also “a number of immunology products as well as some cancer products coming off-patent.”

Pointing to a 2022 agreement between Organon and Shanghai Henlius Biotech that gave Organon rights to Henlius’ HLX11 pertuzumab rival to Perjeta and HLX14 denosumab version of Prolia/Xgeva outside China (see sidebar), Ali said “we’ll be launching in 2025 and 2026 the biosimilar of pertuzumab as well as the biosimilar of denosumab,” with the breast cancer and osteoporosis treatments aligning with Organon’s core focus area of Women’s Health.

“Ultimately,” Ali said, “we see really good growth with our biosimilars business, continued stability and growth with our Women’s Health business and a stabilization and even a little bit of growth on our Established Brands. So we’re in a good position.”

Moreover, he observed, “we’ve got plenty of cash at our disposal” that would allow the firm to “really focus on execution and delivering,” including driving its existing Hadlima (adalimumab-bwwd) biosimilar business.

Predictions Borne Out On Humira Competition

Recalling comments made a year ago at the J.P. Morgan Annual Healthcare Conference event in 2023, Ali suggested that his cautious predictions for the adalimumab market had subsequently proved accurate.

“You know, I was sitting here a year ago, and I was actually the person who was kind of signaling that it’s going to be a slower uptake, that people should be ready for that,” the CEO recollected. “And I think a lot of people were very bullish and I was more kind of being conservative.”

Last year, Ali also correctly predicted that discounts offered for adalimumab biosimilars would rapidly reach the region of 80%-90% (see sidebar).

Taking stock of the past year of competition – since Amgen’s initial first biosimilar launch in January 2023 and the subsequent deluge of multi-source competition in July (Also see "Fresh Wave Of Adalimumab Biosimilars Hits US" - Generics Bulletin, 3 Jul, 2023.) – Ali claimed that “we are now the number one biosimilar of Humira, albeit it’s a smaller-scale business that is growing.”

“We beat everybody else and clearly the value proposition that we’ve come to the market with has been picked up,” Ali suggested, following reports last year that Organon was offering an 85% discount for its Hadlima version compared to the brand wholesale acquisition cost.

Other suppliers have also claimed to have the leading Humira biosimilar in the US, with Sandoz last year suggesting that its Hyrimoz (adalimumab-adaz) version had “more lives covered than any other competitor.” (Also see "Sandoz Mulls At-Risk Launch For US Natalizumab" - Generics Bulletin, 30 Oct, 2023.)

“PBMs may go to two or three [Humira biosimilars], but I think three is the max.”

But Ali insisted that, over time, “low-WAC type of businesses – Medicaid, Medicare, Blue Cross Blue Shield, VA [the US Department of Veterans Affairs], prisons – all those things that kind of look for the lowest net price” would gravitate towards Organon’s Hadlima, as “we fit into that world very well.”

And “we also fit into the PBM [pharmacy benefit manager] world,” the CEO attested, suggesting that there was still “a lot of activity, a lot of churn in that system” amid fresh developments like CVS Caremark removing branded Humira from formularies in favor of biosimilars, and CVS subsidiary Cordavis striking a deal with AbbVie for co-branded Humira. ( (Also see "Adalimumab Uptake Set For A Boost As CVS Drops Humira From Formularies" - Generics Bulletin, 9 Jan, 2024.)

“All of that means that 2024 is still a year of market formation,” Ali summarized. From “2025, you’ll start to see more of the pickup.”

Suggesting that if Humira revenue was worth “let’s say, $20bn” at its height, then Ali said that assuming 90%-level discounting, the adalimumab market value “ultimately comes down as I said last year to $2bn.” And “we’re one of three [leading biosimilars],” he declared. “It’s still a very good business for us. And it will get us to the place where we want it to be in terms of what we’ve said about our peak revenue for Hadlima in the US.”

In 2024, the biosimilar adalimumab market would “see sequentially more penetration quarter-by-quarter, definitely,” Ali predicted. “There’s no doubt about that, because that low WAC, low net cost business will continue to churn to want to be able to get to a place where they take on biosimilars as opposed to the originator. So it’s just going to be a slower build.”

“So we’ll reach that peak revenue – I’ve always signaled a couple of hundreds of millions for the US – but it’s a time continuum.”

Adalimumab Interchangeability More Significant Than Expected

Asked whether the adalimumab market would support seven or eight players – or whether some biosimilars would start to drop out of contention entirely – Ali responded that “I’ve always said that there will be two or three that emerge, ultimately, at the end of the game. And I still feel that way.”

For any payor, “if you’re not getting the uptake, if you’re not getting the pull through, they’ll pull you off formulary because essentially you’re just wasting space,” Ali commented.

“In the case of CVS, they went for a system where there will be one biosimilar and then one originator; in the other case of other PBMs, they may go to two or three, but I think three is the max.”

“And I think that what you’ll see is kind of emerging for the market in the long run, is that there’ll be three winners that come through, and that’s fine for the kind of market that I’m saying is going to end up being [left], along with AbbVie.”

Finally, on the significance of interchangeability – with two interchangeable adalimumab biosimilars currently in the market and more on the way (see sidebar) – Ali admitted that “that’s the one area I might have missed a year ago. I didn’t think it was going to be as important as it’s emerging to be.”

For Organon’s Hadlima, an interchangeability study “is finished, and we submitted it to the US Food and Drug Administration,” Ali indicated. “We expect to have that indication wrapped up and launched in the summer of this year.” And “what that will mean is that, in specialty pharmacies, when patients are coming in and get the sticker shock in terms of the out-of-pocket costs, they’ll be able to move that patient over if you have interchangeability status without any issues.”

Happy With Partnership Model For Biosimilars

Finally, commenting on Organon’s biosimilars business overall, Ali said that the firm remained happy with its partnered model rather than being a fully-fledged developer and manufacturer of biosimilars.

“I think we’re in a good place because we’re not end-to-end, so we don’t have to invest capital in terms of manufacturing, research and development, regulatory pathways,” Ali outlined. “We are just focused on the commercial partnership.”

“There are a number of developers out there, including Samsung and Henlius and others that we’ve done business with, where we feel the return on invested capital is really good because you don’t have a lot of investment on the upfront expense, in terms of commercialization of these products,” he explained. “You just have to have really good key account processes and other things that you need to do, to get the business moving.”

The company was “always looking for potential partnerships like the one with Henlius, with those two assets,” Ali indicated, revealing that “we’re looking at more assets in the space.” And the key criterion for Organon, the CEO said, would be “when are you coming to market – are you among the first, say, two or three?”

“That to me is number one. If you’re actually going to be in the second group of, say, three to six, it’s probably not worth your while.”

So overall, biosimilars were currently proving to be “a very nice, opportunistic play” for Organon, Ali concluded.” Let’s see where it plays out to the end of the decade when the IOs come off and then we’ll start to see what’s there in the future in the cards for that.”