Alvotech's Simponi Biosimilar Faces FDA Setback, Delaying Market Entry

Alvotech, an Icelandic biosimilar specialist, has encountered another regulatory hurdle in its quest to bring more affordable alternatives to popular biologic drugs to the U.S. market. The company recently announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for its biosimilar candidate AVT05, a proposed copycat version of Johnson & Johnson's anti-inflammatory drug Simponi (golimumab).

Manufacturing Issues Derail FDA Approval

The CRL, received by Alvotech, cites "certain deficiencies" observed during a July inspection of the company's production facility in Reykjavik, Iceland. These manufacturing-related issues must be resolved before the FDA can approve the AVT05 application, which includes both a prefilled syringe and an autoinjector version of the Simponi biosimilar.

Robert Wessman, Alvotech's CEO, expressed disappointment but remained optimistic, stating, "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."

Impact on Revenue and Production

In response to this setback, Alvotech has revised its financial outlook for 2025:

• Total revenue projections have been lowered to between $570 million and $600 million, down from the previous estimate of $600 million to $700 million.
• The company anticipates a decrease in earnings before interest, taxes, depreciation, and amortization (EBITDA) due to continued investments in resolving facility issues.
• A temporary slowdown in production is expected as the company addresses the FDA's concerns.

Competitive Landscape and Future Prospects

Despite this delay, Alvotech and its partner Teva Pharmaceutical Industries remain poised to potentially be the first to introduce a Simponi biosimilar to the U.S. market. Currently, there are no FDA-approved biosimilars for Simponi, which generated less than $300 million in U.S. sales during the first half of 2025.

The partnership between Alvotech and Teva, established in 2020, now encompasses nine biosimilar candidates. The collaboration has already yielded FDA approvals for biosimilars of AbbVie's Humira and Johnson & Johnson's Stelara, despite previous regulatory challenges related to the Reykjavik facility.

As Alvotech works to address the FDA's concerns, the company maintains that its Reykjavik plant remains cleared for the production of other commercial products. The biosimilar manufacturer is confident that its ongoing investments in the facility will support future growth and launch plans, potentially strengthening its position in the competitive biosimilar market.