The Comeback Begins? Positive Signs Seen For Humira Biosimilars In US

After a slow start in 2023, biosimilar versions of Humira (adalimumab) are starting to gain ground in the early months of 2024.

The latest data points to Sandoz increasing its share on a weekly basis – in the wave of pharmacy benefit manager CVS Caremark removing branded Humira from national formularies in favor of biosimilars (see sidebar) – while Alvotech and partner Teva are looking to bolster their position ahead of launching an interchangeable 100mg/ml version that received approval in February.

And the latest figures from Samsung Bioepis’ quarterly US biosimilars report suggest that the market share captured by biosimilars altogether has doubled in Q1 – albeit only up to 4% from 2% at the end of 2023.

Multiple analysts at the end of last week identified a sharp upwards trend for Sandoz’s Hyrimoz (adalimumab-adaz) biosimilar in the US, as a result of the firm’s partnership with CVS and its Cordavis subsidiary. (Also see "CVS Lines Up Sandoz’s Adalimumab Biosimilar For US Biosimilars Subsidiary" - Generics Bulletin, 25 August, 2023.)

Evercore ISI had been one of the earliest to note that Hyrimoz sales were rising, and said on 19 April that – with two full weeks of prescription data – it had seen prescriptions for the Sandoz biosimilar grow “from ~8,294 NRx in the 5 April ending week to ~10,266 NRx in the 12 April ending week (adding ~1,972 NRx).”

“As a % of total scripts (Humira + biosimilars), Humira biosimilars were 19% in the past week vs. 15% in the week ending 5 April,” Evercore ISI said.

Similarly, in a 19 April note Deutsche Bank said that IQVIA data for the previous week showed branded Humira with around 80.5% of adalimumab prescriptions, “while Cordavis' Hyrimoz biosimilar share has now crept up to 15.3% (+3.7% w/w).”

This recent uptake was “much faster than other Humira biosimilars from Amgen, Boehringer, Biocon, Coherus etc.,” Deutsche Bank observed, while “branded Humira creeping down to 80.5% market share is now already half the erosion mentioned for AbbVie’s US Humira FY24 sales to be down -36% year-on-year (or around $7.8bn), which is supposed to be mainly from pricing pressure.” (Also see "AbbVie: Humira Competition Has Gone ‘Exceptionally Well’ For Us" - Generics Bulletin, 24 January, 2024.)

However, a separate note on the same day from Wells Fargo suggested that while the downwards trend for branded Humira “appears to be a marked stepdown in volume, AbbVie notes this has been contemplated in guidance and should eventually normalize.” The IQVIA data “seems to reflect initial switch in CVS template formularies,” Wells Fargo concurred.

Leerink also weighed in on 19 April, suggesting that it was “unclear if AbbVie has been surprised by the biosimilar Humira volume increase, considering that CVS announced its plans on 3 January and AbbVie subsequently provided 2024 guidance on 2 February.” Updated commentary and guidance from AbbVie was expected when the originator reported its Q1 results on 26 April, the analyst noted, adding that “we do not know if any other major payers will effect a hard switch in the future like CVS has done.”

More broadly, Leerink observed, “we note there has been pressure on payers to better support biosimilars.” (Also see "Biosimilars Council Calls Out PBMs For Suppressing Humira Biosimilars Adoption" - Generics Bulletin, 22 April, 2024.)

Alvotech Deal Aims To Expand Access

“In our view, the optics of Cordavis continuing to pick up share shows there is now a formula to quickly take a good chunk of market share away from AbbVie/branded Humira,” Deutsche Bank suggested.

The analyst said this was “particularly pressing since Alvotech’s Simlandi (adalimumab-ryvk) launch is also looming.” Partner Teva plans to introduce the interchangeable 100mg/ml biosimilar imminently (see sidebar).

Alvotech has in the last few days announced that it and Teva have signed a “long-term agreement with a strategic partner” to “further enhance access to adalimumab-ryvk in the US market.”

However, the developer declined to provide specific details other than to indicate that the deal “broadens patient access and further commitment to availability of vital biologics in the US and globally.”

Alvotech founder, chairman and CEO Robert Wessman indicated that “this new partnership agreement supports our financial guidance and reflects Alvotech’s strong commitment to increasing patient access to more affordable healthcare.”

Responding immediately after the deal was announced, Deutsche Bank emphasized that “Simlandi has the trifecta of high-concentration, citrate-free and interchangeable status. If Alvotech/Simlandi can also manage to quickly take 10% share like Hyrimoz, then AbbVie’s FY24 guide for US Humira may be exposed to a down revision.”

Samsung Bioepis Q1 Data Reflects Gradual Ramp-Up

The latest developments for US adalimumab rivals bolster early signs of optimism reflected in Samsung Bioepis’ latest US biosimilars market report, which is published on a quarterly basis.

Samsung Bioepis had at the end of last year provided the stark statistic that after almost a year of competition, adalimumab biosimilars had together captured just 2% of the market (see sidebar).

These low levels of uptake have already driven some suppliers to revise their strategy for the US market.

Boehringer Ingelheim recently cut US sales staff linked to its Cyltezo (adalimumab-adbm) version, acknowledging that “due in large part to the complexities of a complicated landscape and several challenges with PBMs keeping Humira on formulary, adoption of Humira biosimilars at scale has not reached its anticipated potential.” (Also see "Boehringer’s Slashed Cyltezo Salesforce Reflects Struggles For US Humira Biosimilars" - Generics Bulletin, 9 April, 2024.)

However, the latest Samsung Bioepis market report indicated that the 2% share seen at the end of 2023 had doubled just a couple of months later. “As of February 2024, adalimumab biosimilar market share has reached 4%, increasing 2% compared to the previous quarter,” the Q1 report stated.