Teva and Alvotech have braved a long and winding road on the quest to win approval for their biosimilar to AbbVie’s Humira. Now, after multiple manufacturing setbacks, the partners have finally scored their inaugural regulatory nod in the U.S.
Late Friday, the U.S. FDA approved the two companies’ Simlandi as the first citrate-free, high-concentration biosimilar to Humira with a coveted interchangeability tag.
As an interchangeable biosimilar, Simlandi can be subbed in for Humira directly at the pharmacy without consulting the prescriber, much like the process for dispensing generic small-molecule drugs.
As with Humira, Simlandi is cleared to treat 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.
Teva and Alvotech had originally hoped to launch their Humira biosimilar in the summer of 2023. Unfortunately for the partners, an FDA inspection that turned up problems at Alvotech’s plant in Reykjavik, Iceland, scuttled those plans last April. In fact, last year’s rejection marked the second complete response letter the partners received for Simlandi tied to production deficits.
Since then, a host of Humira biosimilars have hit the scene, including interchangeable copycats from Pfizer and Boehringer Ingelheim, plus high-concentration but non-interchangeable versions from Sandoz and others. Nevertheless, the biosimilar assault on Humira has been milder than expected.
What sets Simlandi apart, according to Alvotech CEO and Chairman Robert Wessman, is the fact that the drug mirrors Humira’s high-concentration format, which comprises close to 90% of Humira sales in the U.S. market. And it’s also “interchangeable to the form that dominates the market today,” Wessman said in an email interview.
Given its unique status as a high-concentration interchangeable biosimilar, Simlandi is also expected to win market exclusivity, the CEO added.
Overall, Wessman figures the approval could drive “further biosimilar conversion.” Existing biosimilars of Humira in the U.S. haven’t gained much traction because they are either low concentration or non-interchangeable, the CEO said.
In terms of launch preparations, Alvotech and its U.S. commercial partner Teva are ready to roll, Wessman said, adding that the companies expect to launch Simlandi in the “near term.”
The partners figure marketing Simlandi will take a “multi-part approach,” he explained. Besides the advantage of its formulation and interchangeable tag, supply will also be a determining factor, which is why, according to Wessman, Alvotech invested in its manufacturing infrastructure “well before we expected to receive approval.”
Further, the autoinjector device used to deliver Humira biosimilars is crucial, Wessman said, noting Alvotech has “invested significant time and effort to make [its autoinjector] as patient-friendly as possible.”
Wessman’s comments echo those of Shreehas Tambe, CEO of Biocon Biologics, which launched its own Humira biosimilar, dubbed Hulio, in July. Speaking to Fierce Pharma last fall, Tambe highlighted three factors that would determine its biosimilar’s success: the right pricing strategy, reliable global supply and the medication’s delivery device.
Despite Alvotech’s current confidence, the company has had to overcome several hurdles on its path to the FDA finish line.
Last April, Teva and Alvotech received their second FDA rejection in as many years for their biosimilar, at the time known as AVT02. The complete response came after the FDA issued Alvotech a Form 483 outlining issues at the company’s Reykjavik plant related to quality shortfalls, subpar written records and insufficient computer controls, among other production gaps.
Later in 2023, Teva and Alvotech received a separate rejection of their biosimilar to Johnson & Johnson’s Stelara linked to lingering problems at the Reykjavik plant.
Nevertheless, Alvotech’s past production woes clearly haven’t soured Teva on the companies’ partnership. Last July, the Israeli-American generics giant added two more biosimilar candidates to its collaboration with Alvotech, bringing the total to seven. As part of the expanded agreement, Teva also promised to boost its presence at Alvotech’s Icelandic production site and “actively [support]” the company as it prepared for a return visit from the FDA.
Even with Teva’s support, Alvotech still received yet another Form 483 in Reykjavik early this year, though on this occasion, the FDA only cited a single observation.
At the time, Alvotech’s Wessman said the observation was “readily addressable” and figured the company was still in good shape to win approval for its Humira biosimilar in late February and for its Stelara biosim in mid-April.
Now, it appears Wessman’s faith was well placed.
Even after falling off the patent cliff, AbbVie’s Humira remained one of the top grossing drugs in 2023. For all of last year, the medicine generated U.S. sales of nearly $12.2 billion.