Substitutable biosimilars expanded to fourteen biological groups in pharmacies

The Ministry of Health, Families, Autonomy and People with Disabilities published in the Official Journal of the French Republic on October 27, 2026 (JORF No. 0251) a decree referenced NOR SFHS2628312A. Signed on October 22, 2026, this text amends the decree of September 17, 2026, by entirely replacing the annex that establishes the list of similar biological groups substitutable by the community pharmacist. The new list contains fourteen groups, from filgrastim to denosumab.

The legal framework for substitution

The text is adopted for the application of paragraph 2 of Article L. 5125-23-2 of the Public Health Code, which authorizes the pharmacist to dispense a biosimilar medicine instead of the prescribed biological medicine. The system has already seen several versions this year: an initial decree of April 10, 2026, established the initial list, followed by a decree of September 17, 2026, published in JORF No. 0221 on September 22, 2026, under NOR SFHS2624801A, which amended it. Article 2 of the new decree provides that the annex from this latter version is replaced by the present annex, which therefore entirely supersedes the previous one.

Six new specialties in the annex

A comparison of the two annexes reveals targeted additions, group by group:

• Filgrastim: GRASTOFIL® disappears from the list, which retains ACCOFIL®, NIVESTIM®, RATIOGRASTIM®, TEVAGRASTIM®, ZARZIO®, and ZEFYLTI® against the reference NEUPOGEN®.
• Ranibizumab: RANLUSPEC® joins RANIVISIO®, BYOOVIZ®, RIMMYRAH®, XIMLUCI®, and VISLYFA®, alongside LUCENTIS®.
• Enoxaparin: ENOXAPARINE EG® and ENOXAPARINE ZENTIVA® are added to the series of low molecular weight heparins substitutable for LOVENOX®, now numbering eleven.
• Aflibercept: four new references, VGENFLI®, OPUVIZ®, EIYZEY®, and EYLUXVI®, join eight other biosimilars of EYLEA®.
• Ustekinumab: USYMRO® and USGENA® complete a list that reaches ten biosimilars of STELARA®.

The annex specifies in a note, for aflibercept, that the specialties EYLEA 114.3 MG/ML, solution for injection and solution for injection in a pre-filled syringe, have no associated biosimilar medicine.

The fourteen groups of the annex

The list now covers the following groups, each linked to a reference biological medicine:

• Filgrastim (NEUPOGEN®) and pegfilgrastim (NEULASTA®) ;
• Ranibizumab (LUCENTIS®) and aflibercept (EYLEA®) ;
• Teriparatide (FORSTEO®) and etanercept (ENBREL®) ;
• Adalimumab (HUMIRA®) and ustekinumab (STELARA®) ;
• Enoxaparin (LOVENOX®) and follitropin alfa (GONAL-F®) ;
• Epoetin (EPREX®) ;
• Denosumab in two distinct groups, according to PROLIA® and according to XGEVA® ;
• Omalizumab (XOLAIR®), for which OMLYCLO® is the only listed biosimilar.

What the pharmacist must verify at each dispensing

Article 1 recalls six general obligations, applicable to all groups:

• the prescriber informs the patient of the possibility of substitution;
• the pharmacist informs the patient, during dispensing, of the actual substitution and the storage rules for the specialty delivered;
• they mention on the prescription the name of the medication actually dispensed and inform the prescriber;
• they record the name of the medication delivered and its batch number for traceability purposes;
• they ensure the continuity of dispensing the same medication during subsequent dispensations.

Added to this are conditions specific to certain groups: substitution at an identical active substance dosage for etanercept, adalimumab, enoxaparin, and epoetin; for adalimumab, a prohibition on delivering a biosimilar with an injection volume higher than the prescribed medication; the provision of dummy administration devices by laboratories and support for the patient in learning the new device; the possibility for the patient to return to the specialty initially delivered. For follitropin alfa, the pharmacist must guarantee the administration of the exact prescribed dosage when switching between multi-dose and single-dose pens. For omalizumab, particular attention is required due to differences in cap colors. Finally, for ustekinumab, substitution remains limited to the scope of the marketing authorization (MA) of the specialty delivered, as indications may differ from those of STELARA®, particularly for pediatric Crohn’s disease and ulcerative colitis.

The decree comes into force upon publication: pharmacies have therefore had, since October 27, 2026, a consolidated list of fourteen groups and expanded references, which mechanically increases the possibilities for substitution in the event of shortages or supply tensions, while increasing the traceability and information obligations weighing on the pharmacist.

Official Journal of the French Republic, JORF No. 0251 of October 27, 2026, order of October 22, 2026 amending the order of September 17, 2026 establishing the list of similar biological groups substitutable by the community pharmacist, NOR SFHS2628312A.