Alvotech FDA Approval Clears Path To Challenge Humira

It’s been a long time coming, but Alvotech has finally snagged US Food and Drug Administration approval for its Teva-partnered US biosimilar rival to Humira (adalimumab). And despite coming to the market later than their peers, the firms believe that the unique attributes of Simlandi (adalimumab-ryvk) – which has been approved as the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira – will position them to robustly challenge AbbVie’s brand as well as the other biosimilars already in the market.

Alvotech and Teva’s AVT02 adalimumab candidate had been repeatedly knocked back by the FDA due to deficiencies observed by the agency at Alvotech’s Reykjavik facility, with multiple complete response letters issued over the application. (Also see "Alvotech And Teva To Miss US Adalimumab Launch After Further FDA Setback" - Generics Bulletin, 29 Jun, 2023.)

Nevertheless, the firms remained committed to their partnership, agreeing “increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility” as they worked towards approval. (Also see "Teva Doubles Down On Alvotech Biosimilars Partnership" - Generics Bulletin, 24 Jul, 2023.)

And in recent weeks Alvotech had revealed that a January FDA reinspection of the plant had resulted in a single, “readily addressable” observation that would allow not only for AVT02 to be approved in late February but also for the firm’s AVT04 rival to Stelara (ustekinumab) to receive approval on 16 April ahead of launch early next year (see sidebar).

With Simlandi now approved by the FDA – for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis – Alvotech and Teva said they expected to launch the product “imminently.”

Robert Wessman – founder, chairman and CEO of Alvotech – said the approval represented “an important milestone in Alvotech’s journey to offer broader access worldwide to more affordable biologics, following approvals of our biosimilars in other global markets.”

“We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the US where biologics represent well over 40% of all pharmaceutical spending,” Wessman observed. “An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the US.”

“The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with interchangeable status.”

Those market dynamics are in dire need of changing from the perspective of biosimilar suppliers. Despite a slew of adalimumab biosimilars launching in 2023, altogether biosimilars managed to capture just 2% of the market from the originator by the end of last year (see sidebar).

But while Simlandi represents the tenth Humira biosimilar to be approved by the FDA, the product is the first high-concentration (100mg/ml), citrate-free adalimumab biosimilar that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.

“An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs,” Alvotech noted. “As the only interchangeable adalimumab biosimilar with the high-concentration formulation, Simlandi can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.”

And “while both low-concentration [50mg/ml] and high-concentration [100mg/ml] strength biosimilars of Humira are marketed in the US today,” Alvotech acknowledged, “nearly 88% of US prescriptions for adalimumab are for the high-concentration presentation.”

Alvotech has been clear in the past that it still sees a major opportunity for its biosimilar in the US despite so many rivals having already launched last year. Chief commercial officer Anil Okay last year suggested that “the story of retail biosimilars in the US, and for Humira for that matter, is still being written.” Given Simlandi’s unique attributes, Okay said, “we maintain our view that this differentiation is a significant market advantage,” with Alvotech perceiving adalimumab as “a long-term opportunity for the company.” (Also see "Alvotech Says Adalimumab Story Is ‘Still Being Written’ Ahead Of ‘Critical’ Inspection" - Generics Bulletin, 8 Sep, 2023.)

Partner Teva also commented on the approval, which is the first under the pair’s US marketing alliance. Eric Hughes – Teva’s executive vice president for global R&D and chief medical officer – underlined that the approval of Simlandi “marks the first high-concentration, citrate-free biosimilar to Humira with interchangeable status.”

“Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients,” Hughes summarized. “This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the US.”