FDA Rejects Alvotech’s Biosimilar AVT05 for Simponi Citing Manufacturing Deficiencies

The U.S. Food and Drug Administration (FDA) has declined to approve Alvotech’s proposed biosimilar, AVT05, which is intended to replicate Johnson & Johnson’s Simponi. The rejection stems from concerns related to manufacturing processes.

The FDA cited deficiencies in the production of AVT05 as the primary reason for its decision. Specific details regarding the nature of these manufacturing issues were not disclosed in the announcement. Simponi, a medication used to treat autoimmune conditions such as rheumatoid arthritis and ulcerative colitis, is currently marketed by Johnson & Johnson. Biosimilars are designed to provide more cost-effective alternatives to existing biologic treatments while maintaining similar efficacy and safety profiles. Alvotech has not yet provided further information on how it plans to address the FDA’s concerns or whether it will resubmit its application after resolving the identified issues.

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Date: November 4, 2025

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