Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partners’ Humira biosimilar earlier this year—have triggered another FDA rejection.
This time, the FDA action hits the partners' proposed copycat of Johnson & Johnson’s top-selling drug Stelara.
The silver lining? Teva and Alvotech still have plenty of time to sort things out, thanks to a recent settlement with J&J that permits the biosimilar makers to launch their version of the inflammatory disease blockbuster no later than Feb. 21, 2025.
Alvotech on Thursday said the FDA shot down its biosimilar candidate to Stelara, called AVT04, over “certain deficiencies” uncovered by the FDA during a reinspection of the Reykjavik factory in March. The production shortfalls, which have informed three rejections of Teva and Alvotech’s Humira biosim since last September, must be resolved before the companies’ Stelara biosimilar application can be approved, Alvotech said in a release.
Given the fate of the partners’ Humira biosim and the fallout from Alvotech’s FDA inspection, the rejection of AVT04 in the U.S. was to be “expected,” Alvotech said. Manufacturing concerns aside, the FDA raised no other issues with Teva and Alvotech’s application, which the partners plan to resubmit “shortly.”
Upon resubmitting AVT04’s approval filing, Alvotech expects the FDA will likely take another six months to review its Stelara biosimilar.
Meanwhile, Alvotech is already looking forward to its next visit from the U.S. drug regulator, according to the company’s chairman and CEO Robert Wessman. Based on latest communications with the FDA, Alvotech expects the agency will reinspect its Reykjavik plant at the start of 2024, Wessman said in a statement.
Back in June, J&J inked an agreement granting Alvotech and Teva a license for their Stelara biosimilar in the U.S. The February 2025 launch timeline would put the partners a little more than a month behind Amgen, which has signed a separate deal with J&J to potentially launch its own Stelara copycat no later than Jan. 1, 2025.
Like Teva and Alvotech, Amgen has yet to win the FDA’s blessing for its proposed biosimilar.
Problems at Alvotech’s Reykjavik plant first surfaced last September with the FDA’s initial rebuff of the company’s Humira biosimilar AVT02.
As with Stelara copycat AVT04, the FDA flagged “deficiencies” following an inspection of Alvotech’s plant. Subsequently, the FDA published a Form 483 that highlighted issues related to procedural controls, management of manufacturing deviations and more.
In April, Teva and Alvotech received a second complete response letter rejecting AVT02, along with another Form 483 from the FDA singling out issues at Reykjavik pertaining to quality shortfalls, subpar written records, problems with incoming stoppers and insufficient computer controls, among other manufacturing gaps.
AVT02 was rejected once again in late June, also due to concerns around Alvotech’s facility.
Despite Alvotech’s recent production odyssey, Teva in July doubled down on the companies’ partnership, pledging increased manufacturing involvement and $40 million in funding for its partner.
As part of the expanded pact, Teva will boost its presence at Alvotech’s Icelandic production site and previously said it was “actively supporting” the company on-site to prepare for its next FDA inspection.