Federal Register #2026-15630

FDA Notice: Draft Guidance on Biosimilar Product Packaging and Device Components

This opportunity involves a notice from the Food and Drug Administration (FDA) regarding draft guidance for biosimilar product packaging and device components. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are specified in this notice - No products or services are being requested or procured - Key Details: - The draft guidance addresses considerations for container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products - Provides recommendations for delivery devices, product quality, and user interface evaluation for combination products - Encourages early engagement with FDA for products differing from reference products - The notice is informational and seeks public comments on the draft guidance - No part numbers, quantities, or procurement requirements are included

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This guidance is intended to assist applicants in developing container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. It expands on and clarifies FDA's recommendations regarding delivery devices and container closure systems as described in previous guidances. The draft guidance also addresses considerations for evaluating the user interface of combination products and encourages early discussions with the FDA for interchangeable biosimilar combination products in different presentations than their reference products. Comments on the draft guidance are invited by October 2, 2026.

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