Technologie · 13.10.2026

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled 'Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers'. This guidance aims to provide clarity on post-approval manufacturing changes for biosimilar and interchangeable biosimilar products.