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Sandoz Mulls At-Risk Launch For US Natalizumab

Also Provides Detailed Update On US Adalimumab And Wider Biosimilars Business

Executive Summary

As part of a wide-ranging discussion of its biosimilars business as it reported nine-month results, Sandoz has revealed that it is considering launching its Tysabri (natalizumab) biosimilar Tyruko “at risk” in the US, while also providing an update on its progress with adalimumab as well as certain key pipeline assets.

Sandoz has revealed that it is considering launching its Tyruko (natalizumab-sztn) biosimilar rival to Biogen’s Tysabri “at risk” in the US, while litigation with the originator continues.

Buoyed by a court decision earlier this year that refused to grant originator Biogen an injunction to keep Tyruko off the market (see sidebar), Sandoz disclosed as it reported nine-month results that US and European launches of the Polpharma Biologics-partnered natalizumab biosimilar were slated for the first half of 2024.

“Over the summer, Tyruko or biosimilar natalizumab, received US Food and Drug Administration and European Medicines Agency approval,” observed Sandoz CEO Richard Saynor. (Also see "FDA Approves Natalizumab For Sandoz And Polpharma Biologics" - Generics Bulletin, 25 Aug, 2023.) (Also see "Sandoz Prepares For European Natalizumab Launch As Approval Arrives" - Generics Bulletin, 26 Sep, 2023.)

“If you recall, Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics and has the right to commercialize and distribute the product in all markets. Tyruko will be the only biosimilar to treat relapsing forms of multiple sclerosis and we’re looking forward to being the first company to bring this product to the market at the latest in the first half of next year,” Saynor outlined.

Sandoz expects Tyruko to be “the only biosimilar available in the coming years,” entering a market where “we see a real need for patients, but also the reality is probably no other biosimilar coming into that space.”

With Sandoz’s nine-month results report explicitly stating that European and US launches were “planned in the first half of 2024,” Saynor was asked during the results call whether this implied an at-risk US launch, or confidence in a settlement with Biogen.

“We had a strong outcome in terms of that court case,” Saynor said, referring to Biogen’s failure to secure an injunction. “So clearly, we would certainly consider launching at risk coming to the market, given the strength of that court case and our strength and belief in the patent position.”

Meanwhile, in Europe Saynor said the firm was “confident in terms of the patent position and we’re confident that we will launch in the first half of next year.”

Sandoz Claims Leading Position On Adalimumab In US

Saynor also discussed during the call Sandoz’s position in the US adalimumab market, a few months after the firm became one of multiple biosimilar sponsors to launch Humira rivals simultaneously. (Also see "Fresh Wave Of Adalimumab Biosimilars Hits US" - Generics Bulletin, 3 Jul, 2023.)

With its Hyrimoz (adalimumab-adaz) biosimilar, Sandoz was “excited to be part of the single largest loss of exclusivity event to date,” Saynor underlined, suggesting that “our US team has made tremendous efforts to put us in a leading position in terms of market access and payer coverage amongst the adalimumab biosimilars.”

“All three major pharmacy benefit managers – Express Scripts, Optum/United, and CVS Caremark – have announced coverage for Hyrimoz in the US and we have more lives covered than any other competitor,” Saynor said (see sidebar).

“On top of this, we’ve signed a unique multi-year agreement with Cordavis, a wholly-owned subsidiary launched by CVS Health, to expand the reach of Hyrimoz to patients in the US,” with the biosimilar “expected to be released and commercialized by Cordavis under their own private label beginning in the first quarter of 2024.” (Also see "CVS Lines Up Sandoz’s Adalimumab Biosimilar For US Biosimilars Subsidiary" - Generics Bulletin, 25 Aug, 2023.)

Taking an overall view of the US adalimumab market, Saynor acknowledged that “as we expected, the market will take time to form, particularly in the absence of Humira being displaced from payer formularies.” (Also see "AbbVie Hails Humira’s Resistance To US Competition" - Generics Bulletin, 28 Jul, 2023.)

“However, we believe we remain uniquely positioned by offering the only adalimumab biosimilar with the same dosing options as Humira through presentations to ensure broad access for patients and vertical integration for supply reliability and consistency. Our number one position outside of the US also provide us with millions of patient days of experience as well as strong expertise in this patient support services.”

“We’ve always guided this will be a build rather than a bang.”

Asked when the market was going to truly “unlock” for adalimumab biosimilars, Saynor said “the feedback we expect as we go through next year – and we think we’ve guided this pretty much from the beginning – is that as formularies rotate round, as payers’ frameworks change, we expect that to start moving. And we’re starting to see some momentum.”

“I guess what I’m happy about today is that we’ve got more lives covered, so all three of the PBMs have us listed. So that gives us extremely broad coverage. But also on top of that, clearly with the partnership with Cordavis … that means that we have contractual volumes that we have to deliver to them, which also will underpin our business both in 2023 and into 2024 and beyond.”

“I think we’ve always guided this will be a build rather than a bang,” Saynor reflected. “What we are seeing, I guess, is more and more, I guess, new patients rather than necessarily switch patients at this point being put on the product. So I’m confident that we’ll build a very attractive franchise over the coming quarters.”

And commenting on pricing trends for adalimumab – in a context in which many suppliers are offering dual pricing options for adalimumab biosimilars, with both high and low list prices but accompanying the high list prices with opaque rebates – the CEO said “clearly at the moment, it’s a market that’s being negotiated.”

But either way, “ultimately whatever pricing at the moment we’re seeing in the US on aggregate is still significantly higher than pretty much anywhere else in the rest of the world. So this is a highly attractive market.”

“We have a great product. We have a really good device. In many ways, we think it’s probably the best device available to patients. And certainly given the intimate relationship between patients and product, we do think this product has the potential to be sticky,” Saynor summarized. “But equally, I’m not naïve to the fact that ultimately it’s [about] what’s on formulary and what insurers are prepared to pay for.”

“So, we have to be competitive in that market and when you look at that from that lens, ultimately you need several things to be successful in this market. Well, we’re number one ex-US. We have millions of patient days of data. We’re vertically integrated, so we have a good cost of goods. We have both strengths [high-concentration 100mg/ml and low-concentration 50mg/ml], and we have a great delivery device.”

“Nobody else really has that combination of things. Rather, they’re sharing their margin with somebody else [or] they only have one presentation and certainly they don’t have the data package that we have. So we’re confident that we can build this franchise quarter-on-quarter going ahead.”

Meanwhile, in Europe Sandoz is planning to launch its high-concentration version of Hyrimoz “by year-end” – following approval in April (Also see "Sandoz Moves Ahead With High-Concentration Adalimumab In Europe" - Generics Bulletin, 4 Apr, 2023.) – with this launch characterized by the firm as “extending the lifecycle of the product” in a competitive European market.

Pipeline Advances Amid Double-Digit Growth For Biosimilars

During the nine-month results call, Sandoz also shared other pipeline updates for its biosimilars business as Saynor highlighted “continued strong demand for our biosimilars,” helping the segment’s sales to grow by 10% as reported and by 11% at constant currencies to $1.59bn, or 22% of Sandoz’s total turnover (see sidebar).

The firm benefited from “strong contributions from Omnitrope (somatropin) and Hyrimoz.” In particular, Sandoz pointed out, “Omnitrope, the first ever biosimilar, overtook its reference medicine to become the leading product in the overall growth hormone market this year.”

Sandoz is continuing to guide that it will launch new products worth around $3bn over the next five years, with around half of this value coming from biosimilars. “So you can see that the proportion of biosimilars is going to grow quite strongly over the next few years,” Saynor underlined.

To support this growth, Sandoz has made various recent moves to bolster the biosimilars business. These include committing at least $400m to building a new biologics production plant in Slovenia as well as a €25m ($26m) investment in expanding its biosimilars development center in Germany and a $90m investment in building a technical development center in Slovenia by 2026. (Also see "Sandoz Unveils $400m+ Investment In Slovenian Biosimilars Plant" - Generics Bulletin, 9 Mar, 2023.) (Also see "Sandoz Unveils Further Biosimilars Investment" - Generics Bulletin, 20 Jul, 2023.)

Sandoz also earlier this year signed a multi-year partnership with Just–Evotec Biologics, covering the development and manufacture of multiple biosimilars with the firm’s proprietary AI-driven technology platform. Saynor highlighted in particular that the deal gave Sandoz the opportunity to access “disruptive technologies complementary to our existing capabilities.” (Also see "Sandoz Makes Major Moves To Bolster Biosimilars Ahead Of Spinoff" - Generics Bulletin, 10 May, 2023.)

And in terms of specific pipeline assets, Sandoz recently struck a deal with Samsung Bioepis to commercialize the firm’s SB17 biosimilar to Stelara (ustekinumab) in the US and in Europe, which Saynor said “further strengthens our position in the immunology space and expands our pipeline to 25 assets.” (Also see "Sandoz Fills Pipeline Gap With Samsung Bioepis’ Ustekinumab" - Generics Bulletin, 11 Sep, 2023.)

Meanwhile, Sandoz was also imminently “expecting the FDA approval for denosumab, which is one of the pipeline biosimilars in bone disease and oncology.” (Also see "Sandoz Maintains Lead On Denosumab As It Files With FDA" - Generics Bulletin, 6 Feb, 2023.)

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