Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this summer that has derailed a leading biosimilar application from partners Teva and Alvotech.
The FDA has issued Alvotech a complete response letter (CRL) on the candidate, coded AVT05, snubbing the company’s application for both a prefilled syringe and an autoinjector biosimilar to Simponi, which also goes by the generic name golimumab.
The FDA handed down its verdict after noting “certain deficiencies” during a July inspection of Alvotech’s production plant in Reykjavik, Iceland, the company said in a Nov. 2 press release. Those manufacturing-related issues must be resolved before the FDA can approve the AVT05 application, Alvotech explained.
The FDA did not find any other faults with the approval filing, and the Reykjavik plant responsible for the CRL remains cleared by the FDA to crank out Alvotech’s other commercial products, the company noted.
On the heels of the plant inspection, Alvotech submitted a detailed action plan to the FDA on how it aimed to fix the issues at its plant, the company’s CEO, Robert Wessman, explained in a statement.
“While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.,” he said.
Alvotech did not discuss the particular observations the FDA made in its CRL announcement.
The regulatory hiccup has prompted Alvotech to downgrade its earnings expectations for the year. The company now predicts total 2025 revenue will land between $570 million and $600 million, lower than a previous range of $600 million to $700 million.
The company also figures its earnings before interest, taxes, depreciation and amortization will come in lower for the year, attributing the downgraded profit forecast to “expected continuation of investments related to resolving certain facility issues.”
Resolving those issues also necessitates “a temporary slowdown in production,” although Alvotech said it expects its future growth and launch plans to benefit from the investments it’s making at the Reykjavik site moving forward.
Icelandic biosimilar specialist Alvotech first linked up with generics giant Teva back in 2020, when the partners forged a commercialization alliance around five of Alvotech’s biosimilar candidates, including AVT05. That deal, which has since swelled to include nine products, sees Teva in charge of U.S. commercialization, while Alvotech handles development and manufacturing of the partnered biosimilar medicines.
The partners have already pushed two biosimilars through the FDA in the form of biologic copycats to AbbVie’s Humira and J&J’s Stelara, and they were hoping to be the first to score a thumbs-up for a Simponi biosim, too.
Over the first six months of 2025, Simponi—initially approved in 2009 and cleared to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis—generated U.S. sales of less than $300 million, Alvotech noted in its press release. There are no current FDA-approved biosimilars to Simponi.
Another company out of China, Bio-Thera Solutions, hopes to soon win an approval for its own Simponi biosimilar candidate, although the FDA isn’t expected to weigh in on the drugmaker’s application until well into next year.
The U.S. regulator accepted Bio-Thera’s application in July and aims to issue an approval verdict on the Simponi imitator, dubbed BAT2506, by May 16, 2026.
Alvotech, for its part, has run into repeated issues with the FDA at its Icelandic drug plant. Since the company’s biosimilar accord with Teva began, problems at the Reykjavik facility have led to two CRLs for Teva and Alvotech’s Humira biosimilar as well as a production plant-related rejection for the partners’ Stelara copycat.
Both Teva and Alvotech’s Humira and Stelara biosimilars have since passed muster at the FDA, winning green lights in February 2024 and April 2024, respectively.