FDA Rejects Alvotech’s AVT05 Biosimilar Application

Alvotech (ALVO) shares sank 22% after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its AVT05 biosimilar to Johnson & Johnson’s Simponi, citing manufacturing deficiencies at Alvotech’s Reykjavik, Iceland facility.

The FDA emphasized that the rejection was based solely on facility-related concerns, not on any issues with the biosimilar drug itself.

Key Details

Drug Candidate: AVT05 — biosimilar to Simponi (golimumab)
Issue: Manufacturing deficiencies identified during a prior facility inspection
Location: Reykjavik, Iceland
FDA Status: Complete Response Letter (approval denied pending resolution)
Product Quality: No issues found with the drug’s efficacy or safety

Alvotech stated that it has already submitted a corrective action plan to the FDA addressing the deficiencies.

Financial Impact and Updated Outlook

Due to the additional investments and delays, Alvotech revised its 2025 financial guidance:

Revenue: $570 million – $600 million
Adjusted EBITDA: $130 million – $150 million
The company noted that resolving these issues will lead to a temporary production slowdown as resources are redirected toward compliance and facility upgrades.

Company Response

Alvotech reiterated its commitment to meeting FDA standards and emphasized that it remains confident in the long-term potential of its biosimilar portfolio, which targets major autoimmune and inflammatory diseases.

Industry Context

The setback underscores the stringent FDA oversight for biosimilar manufacturing and the importance of quality assurance in scaling global biologics production.
Competitors in the biosimilar space may temporarily benefit as Alvotech focuses on remediation.