PV Bulletin

Modification of the Reference List of Similar Biological Groups as of September 1, 2026

The ANSM has issued a decision modifying the reference list of biological drugs, including significant additions and compliance requirements.

Primary source: ANSM (France) - News feed

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

The reference list of similar biological groups was updated to include four new biological drugs.

Why it matters

This modification impacts regulatory compliance for biological drugs in France, requiring manufacturers and stakeholders to adjust their processes accordingly.

Action needed

Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

monitoring aligned with regulatory changes

Evidence and confidence

Confidence: highSource updated: Sep 1, 2026

Full briefing

Practical implication

Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.

On September 1, 2026, the ANSM published a decision modifying the reference list of similar biological groups per Article R. 5121-9-1 of the Public Health Code. New inclusions are Etanercept (Enbrel - Fubelv), Tocilizumab (Roactemra - Tuyory), Insuline asparte (Novorapid - Dazparda), and Pertuzumab (Perjeta - Poherdy).

What changed: The reference list of similar biological groups was updated to include four new biological drugs.

Why it matters: This modification impacts regulatory compliance for biological drugs in France, requiring manufacturers and stakeholders to adjust their processes accordingly.

Practical implication: Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.

View original source

  • Source: ANSM (France) - News feed
  • Published at source: 2026-09-01T00:00:00.000Z
  • Discovered by monitor: 2026-09-01T21:42:44.271Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Country Requirement#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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