Amended Citizen Petition - Insulin Detemir Drug Shortage and Biosimilarity Guidance

Detected April 7th, 2026

Summary

Alliance to Protect Insulin Choice submitted amendments to its citizen petition requesting FDA to declare insulin detemir a medically necessary drug in shortage, provide guidance on demonstrating biosimilarity for withdrawn drugs, and permit 503B outsourcing facilities to compound the drug. The petition addresses access concerns following detemir's withdrawal from the U.S. market.

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What changed

The amended petition adds three specific requests to the original citizen petition: declaring insulin detemir a medically necessary drug in shortage, seeking FDA guidance on using comparators to demonstrate biosimilarity for withdrawn drugs including whether reference samples may be obtained directly from manufacturers, and requesting permission for FDA-registered 503B outsourcing facilities to compound insulin detemir while it remains on the drug shortage list.

Affected parties including pharmaceutical manufacturers, 503B outsourcing facilities, healthcare providers, and patients relying on insulin detemir should monitor FDA's response to this petition. If FDA grants the shortage declaration and compounding authorization, it could significantly impact supply chain arrangements and patient access to this insulin formulation.

What to do next

Monitor FDA response to the citizen petition regarding insulin detemir shortage declaration
Prepare for potential biosimilarity guidance from FDA if detemir is designated in shortage
Review compounding authorization eligibility for 503B facilities if petition is granted

Source document (simplified)

Comment

We are submitting an amended petition regarding insulin detemir. A PDF of the full petition with the amendments at the bottom is attached. Here are the amendments we added:

Amendments dated April 3, 2026

The undersigned respectfully request that the U.S. Food and Drug Administration exercise its authorities to:
1. Declare insulin detemir a medically necessary drug in shortage.
2. Provide guidance on how a comparator may be used to demonstrate biosimilarity now that detemir has been withdrawn from the U.S. market, including whether reference samples may be obtained directly from the manufacturer.
3. Permit FDA-registered 503B outsourcing facilities to compound insulin detemir while it remains on the FDA drug shortage list.