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.
The reference list of similar biological groups was updated to include four new biological drugs.
This modification impacts regulatory compliance for biological drugs in France, requiring manufacturers and stakeholders to adjust their processes accordingly.
Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.
Regulatory Intelligence Lead
monitoring aligned with regulatory changes
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.
Published from the regulator source ingestion pipeline after PV impact triage.
Increased vigilance and reporting obligations on illegal peptide products, with an emphasis on monitoring and managing safety signals pertaining to these substances.
Healthcare providers and distributors must immediately identify and quarantine affected products before destroying them after completing the recall actions. Compliance with FDA recall procedures is mandatory.
Review and update labeling processes in accordance with the newly published safety-related changes for affected products.
MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
