FDA Issues Complete Response Letter for Alvotech's Golimumab Biosimilar AVT05

The FDA has issued a complete response letter for Alvotech's Biologics License Application for AVT05, the company's proposed biosimilar to Simponi and Simponi Aria (golimumab), per a November 2, 2025 company announcement. The letter cites deficiencies tied to the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility, which concluded in July 2025.

What did the complete response letter actually say?

The FDA issued the complete response letter for the AVT05 application, filed in both prefilled syringe and autoinjector presentations, per the company's release. The letter noted that certain deficiencies, conveyed following the pre-license inspection of the Reykjavik facility, must be satisfactorily resolved before the BLA can be approved. The agency did not identify any other deficiencies with the application, according to the same disclosure.

That framing matters for how the setback is read. A complete response letter that lists only inspection-related deficiencies, and no clinical or analytical ones, points to manufacturing and quality systems rather than to the biosimilarity package itself. Chief Executive Officer Robert Wessman said the company expects to resolve the outstanding issues and continue working with the FDA, per the release.

Why can a factory inspection decide a biosimilar application?

Biosimilars are approved on a different evidentiary basis than new molecules: the package leans on analytical similarity, pharmacokinetic data and, where required, a clinical study, plus demonstrated control of manufacturing. An FDA pre-license inspection verifies that the plant making the product operates under the required quality system. Deficiencies found in that inspection are application deficiencies until resolved, regardless of how the clinical data look.

The filing history gives the calendar its shape. The FDA accepted the AVT05 applications in January 2025, the first US BLA filing acceptances announced for a golimumab biosimilar candidate, with review expected to complete in the fourth quarter of 2025. The applications cover the product to be commercialized in the US by Teva under the partners' agreement. The complete response letter now extends that timeline, with a revised review goal to be set once the deficiencies are addressed and the application is resubmitted.

What happens after a complete response letter?

A complete response letter pauses an application rather than ending it. The standard sequence runs as follows:

1. The sponsor reviews the deficiencies cited in the letter and completes any remediation at the cited facility.
2. The sponsor resubmits the application once it judges the deficiencies resolved.
3. The FDA assigns a new review goal date, typically six months for a standard resubmission.
4. The agency acts on the resubmitted application, by approval or by a further letter.

Alvotech has not yet disclosed a resubmission date for AVT05. The company also updated its 2025 guidance in the same release, citing a temporary slowdown in production among other factors, with total revenues of $570-600 million and adjusted EBITDA of $130-150 million, per the company's announcement. AVT05 remains unapproved in the US; the reference products Simponi and Simponi Aria continue to be the marketed golimumab options. The company's November 2 statement is the primary disclosure of the letter and its scope.