Quality & complianceOfficial

ANSM fines Biocon Biologics France over Fulphila stock-shortage reporting, decision shows

🇫🇷 ANSM · Thu 05 Nov 2026

The French regulator's 23 October 2026 decision cites rules on shortage notification for medicines of major therapeutic interest, following a risk declaration and an inspection in 2025.

France's medicines agency ANSM has published a decision, dated 23 October 2026, imposing a financial penalty on Biocon Biologics France. The notice went online on 5 November 2026. The extract available does not state the amount, and the operative part of the decision is not included in the text seen.

The recitals show that the case concerns Fulphila 6 mg solution for injection in pre-filled syringe. Biocon Biologics France sent ANSM a declaration of risk of stock shortage for the product on 4 February 2025. ANSM then inspected the company on 16 and 17 July 2025.

The decision notes that Fulphila is indicated to shorten the duration of neutropenia and reduce the incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for malignancy. It belongs to therapeutic class L03A (immunostimulants), which appears on the list of classes containing medicines of major therapeutic interest (MITM) set by an order of 27 July 2016.

The legal basis cited includes Article L. 5121-32 of the Public Health Code, which requires marketing authorisation holders and operators of MITM to tell ANSM as soon as they become aware of any risk of shortage or actual shortage. It also covers the agreed alternative solutions, shortage-management plan measures and information for healthcare professionals and patients. Article R. 5124-49-1 sets out the reporting requirements in more detail.

On procedure, ANSM wrote to the company on 2 June 2026 with its draft sanction decision and invited observations. The company replied on 22 June 2026. The decision also refers to ANSM's financial penalty guidelines of 8 August 2022. The extract is cut off before the agency's findings on the specific breach, so the precise grounds cannot be confirmed from it.

What it means for your team

  • Companies with products in MITM classes should check that shortage and shortage-risk declarations to ANSM are timely and follow the prescribed template and procedure.
  • The sequence of a risk declaration, an inspection, a draft decision and a right to respond shows how ANSM builds a financial penalty case, so teams should keep records ready for inspection.
  • Biosimilar and supportive-care products can fall under MITM obligations, including shortage-management plans and communication with professionals and patients.
  • The full decision on the ANSM website should be read for the amount and the exact grounds before drawing conclusions.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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